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Abid Ali Khan khanbpharm@gmail.

com

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In this episode you will find Standard Operating Procedures for establishing quality assurance practices, such as preparation, maintenance,
definition, classification and change Control of Quality and Master file documentation necessary for your products; recording and reporting
procedure for deviations management; quality concern investigation Process; customer complaint handling procedure; quality audit procedures;
vendor assessment, evaluation and certification procedure; rework procedures for the defective manufactured products; procedures on training
for your staffs and many other procedures according to your need.

All procedures have reference of prepared Forms and Templates for effective record keeping and reporting purposes. Forms are attached at
the end of each procedure. Templates are listed separately.

SOP list

Writing Standard Operating Procedure


This SOP describes standard SOP format that you can create and use immediately for your quality procedures. This SOP has instructions on
how to write a formal Operating Procedures for your systems which your people can follow everyday.

GMP Documents
In this SOP you will find all type of quality and Technical/Master file documents to build up a good quality management system for your
manufacturing sites, definition of documents, their classification, approval requirements and retention requirements. This procedure has
schematic diagrams for your understanding of how different types of documents are prepared and stored in a typical documentation database.

Quality Documentation Change Control


This SOP describes how to generate new quality documents or change control of existing documents, review of quality documents, satellite file
management, role of document author, approver, document control officer and satellite file administrator. In this SOP you will also find
numbering systems of different quality documents like audit files, SOPs, forms, manuals, training files, QA agreements, project files etc and
their effective archiving system.

Documentation Rule
This SOP describes the principles to be followed in GMP documents, entry of data and information, signature requirements and correction
technique of incorrectly entered data or information.

Document Control
In this SOP you will find mainly the role of document control officer during the initiation, creation, circulation and approval of new quality related
documents. It also describes the procedure of modification and review of existing document using a documentation database. Management of
existing and superseded documents is also a part of this procedure. You will see all the forms referred during the instruction are attached at the
end of the procedure.

Master GMP Documents


This SOP particularly focused on the management of master file documents like specifications, control methods, raw materials, finished goods
and packaging specification and test reports, formulation, stability files etc required to generate during the product registration in the market.
This SOP gives instruction on their creation, change control, numbering system, approval requirements and maintenance in a simple master file
database. You will see all the forms referred during the instruction are attached at the end of the procedure.

Deviation Reporting
It is a regulatory requirement to capture all sorts of deviations evolves in your systems in order to maintain the continuous improvement of your
processes and systems. This SOP describes how to categorize the deviations between production, audit, quality improvements, technical
deviations, customer complaints and environmental, health and safety deviations. It describes the management responsibilities of initiating
deviation, capture data, analysis, investigation, determination of assignable causes, generation of management report and initiatives to be
taken on corrective and preventative actions.
Product Shelf Life
This simple SOP describes the meaning of shelf life and provides direction on how to interpret shelf lives and storage conditions for your raw
materials from the Certificate of Analysis, determining expiry date for your finished products by use of raw material date of manufacturing and
their shelf lives.

Vendor Management
This SOP describes the procedure to be followed during the vendor assessment and vendor evaluation for purchasing of raw materials, critical
and non critical packaging components, laboratory supplies, engineering supplies and imported finished goods from the vendor. These
instructions are essential for approving prospective vendor.

Vendor Certification
This procedure aims to describe the process by which a vendor may be certified to supply materials or services. This procedure applies to
vendors that supply a material or service to be used at any stage of manufacture by operations. Here you will get the roles of each department
in the process to certify an approved vendor.

Product Complaint
This procedure covers the receipt, logging, evaluation, investigation and reporting system of all complaints received from customers for the
marketed products. This SOP contains step by step instruction to be followed in the customer complaint management like numbering of
complaint, registration, evaluation of complaints, determination of assignable cause for the complaint deviation, implementation of corrective
and preventative actions, trending of complaints and handling of counterfeit products.

Product Review
This procedure provides a guideline to annual product review which is required to be performed for each product produced for the commercial
market to evaluate data, trends and to identify any preventative or corrective action that would lead to product quality improvements and report
them to management.

Rework
This SOP contains the step by step instruction to be followed when the rework of an in-process or completed finished good is required. This
SOP covers the reworks of in-process manufactured goods where new batch number is introduced for the reworked part and rework of
manufactured finished good keeping the same batch number. This sop also describes how to create rework protocols for each individual case.

Product Identification and Traceability


The purpose of this SOP is to define the method used for the identification of all contributing materials that could affect product quality and to
ensure their full traceability. Here you will find instruction on all the records and documents used for the identification and traceability of
incoming raw materials and out going finished goods.

GMP Audits
This SOP describes the process of planning, performing, reporting and follow-up of different audits for your systems like Internal Quality audit,
Vendor audit, Environmental Health and Safety (EHS) audit, EHS workplace inspection, Housekeeping audit. This SOP also describes the
process to be followed by manufacturing personnel during an audit from a Regulatory authority.

Batch Documentation
This SOP describes the identification of all documentation relevant to a production process in the form of “Batch Documentation Checklists” and
to ensure their collection by completion of the checklists by Authorized Persons. This procedure is based on an example of tablet packaging
process described in the ‘Manufacturing’ category.

Batch Document Evaluation for Release


This procedure describes the process of collection, evaluation and record of batch related document generated during the production of a batch
before an authorized person can release the batch for sale. This procedure is based on an example of tablet packaging process described in
the ‘Manufacturing’ category.

GMP Training
This SOP describes how to design and deliver GMP related trainings for your manufacturing staffs, training assessment design, recording of
assessment and preparation of training reports.

GMP Training Materials


This simple SOP contains instructions on how to write training materials, identification of training requirements, available resources, preparation
of training aid checklists for your manufacturing staffs.

House Keeping Audit


This SOP describes the requirements, checklists and reporting procedure on housekeeping audits. Individual checklist forms are attached at
end of the procedure for different areas like process, laboratory, engineering stores, warehouses. This procedure also describes the handling of
non-compliance found during the housekeeping audits.

Contract Work
The procedure describes the management and control of contract work provided by the contractors for packaging and finished products for your
company as well as control of contract works done by your company on behalf of others.
Raw Material and Packaging Components Sourcing
The purpose of this SOP is to describe the process for approval of an external vendor/manufacturer supplying products to your company. It
covers raw materials (including bulk products for subsidiaries and contract manufacturers), critical packaging components in contact with
product and imported finished goods. The SOP also references affiliated documentation detailing the scope of active materials used and the
approved manufacturers of these materials.

Quality Investigation Process


This procedure contains instruction to be followed when conducting Investigations and to raise and assess Deviation Report when an
Investigation or Incident Investigation occurs. This procedure is to be used in conjunction with Deviation management, which covers the
approval and follow-up activities associated with a Deviation Report. Here you will find collection of information for an incident or a deviation,
steps to be followed for a cross functional investigation, reporting and implementing of the outcomes of investigation.

Change Management System


This procedure provides a standardised procedure and framework for initiating, authorising, planning and implementing any change to a GMP
system.

Product Change Management requires that all planned permanent changes that have the potential to impact on regulatory filings or the quality
of an active pharmaceutical ingredient or drug product must be evaluated, reviewed and approved. It also requires that the site procedure must
include provision for effectively tracking all quality and regulatory changes and provide a mechanism for review and approval by the Site Quality
Team for all changes

Cross functional investigation


This procedure describes the guidelines for initiating, communicating, conducting and documenting Cross-Functional Investigations (CFI)
related to process, system, product, material, facility and laboratory deviations. A Cross–Functional Investigation is an extended investigation
conducted in order to identify a Root Cause.

Quality Control Laboratory Procedures

In this episode you will find practical procedures on Retest Dating of Raw Materials; Calibration Policies for Laboratory Instruments; Archiving
Laboratory Documentation; Management of Reference Substances; GLP requirements of Laboratory Workbook; Creation of Certificate of
Analysis; Managing Analytical Reagents; Laboratory Waste Management; Managing of Retention Samples in Laboratory; Laboratory Supplier
Approval; Laboratory Results-Out Of Specification Investigation; Raw Materials-Laboratory Testing and Documentation; Finished Goods-
Laboratory Testing and Documentation; Preparation and Maintenance of Stability Protocols (pharmaceuticals); Stability and Trial Testing
Procedure (pharmaceuticals).

SOP lists

Retest Dating
The purpose of this procedure is to describe how to run the expired stock report; to describe how to define the requirements for the retesting
and assignment of storage periods for active ingredients, excipients and raw materials; to instruct retesting procedure and to determine the
status of a finished goods batch with a shorter shelf life.

Calibration of Laboratory Instruments


This SOP describes the calibration policies of laboratory instruments/ equipments. It describes labeling and security requirements of laboratory
instruments/ equipments. This SOP also describes the investigational steps to be required in the case of failed calibration.

Archiving of Laboratory Documentation


This procedure describes retention and disposal procedures of laboratory documentation, general laboratory documentation system that
includes handling of rejected raw material and finished product reports, finished goods certificate of analysis, finished goods register, raw
material certificate of analysis, raw material register, trend cards, procedure for long term document retention.

Reference Substances
This SOP describes the ordering, referencing, storing, coding, use and general register maintenance of primary and impurity reference
substances, primary reagent reference solutions, secondary raw material reference substance, assay testing procedure of secondary raw
material reference substance, use of secondary raw material reference substance in the laboratory routine analysis, determination of expiry
date and re-test date of reference substances.

Laboratory Workbook
This SOP describes types of laboratory workbooks, general and GMP requirements of using workbooks, analytical data entry in the workbook,
formatting of laboratory workbooks for routine testing, experiments and trials, workbook retention policy, instruction on data entry for incomplete
experiments and additional data.

Certificate of Analysis
The purpose of this procedure is to define the content and format of a Certificate of Analysis (C/A) and Certificate of Manufacture (C/C) and to
provide guidance for issuing a Certificate of Analysis or Certificate of Manufacture and to locate the appropriate data required for this task.
Analytical Reagents
This procedure identifies the need for all analytical reagents and solutions prepared from the reagents, to have an assigned expiry date and
storage conditions recorded on the label. Here you will find the procedure for purchase and management of analytical reagents and laboratory
prepared reagents.

Laboraotry Waste Management


This simple procedure describes how to dispose off laboratory generated wastes of toxic, explosive, flammable, corrosive, oxidizing and
biologically damaging natures.

Laboratory Retention Samples


The purpose of this SOP is to describe the finished good and raw material sample retention procedures, products manufactured and/or
received onsite and/or chemically tested by the Laboratory.

Laboratory Supplier Approval


In this simple SOP you will find the procedures for approving laboratory suppliers and criteria for the purchase of equipment, instrumentation,
consumables, durables and glassware for the laboratory.

Laboratory Results Out Of Specification Investigation


This procedure describes the actions to be taken by an analyst in the event the result of a test does not conform to raw material/components or
finished products specifications for physical and chemical tests. An out of specification (OOS) result does not necessarily mean the batch under
investigation fails and shall be rejected. The OOS results shall be investigated and the findings of the investigation, including re-test results
shall be interpreted to evaluate the batch and reach a decision regarding release or rejection.

Laboratory Testing for Raw Materials


This SOP describes the procedure for sampling, location, pre-testing, testing and documentation of all raw materials and components subject to
test, out of specification results, microbiological tests and release procedure for passed raw materials and components.

Laboratory Testing For Finished Products


This SOP describes the procedure for sampling, location, pre-testing, testing and documentation of all finished products subject to test,
reagents and standards to be used for analysis, management of out of specification results, microbiological tests and release procedure for
passed finished goods.

Stability Protocols
This procedure describes the preparation and management of Stability Protocols for marketed products. This procedure is applicable to all
protocols for stability studies on commercial products. The responsibility of the commercial Site Stability Manager for creating and maintaining
protocols that are required for studies that came as a result of validation or process deviation.

Trial Testing
To describe the steps necessary to ensure the effective control of stability and trial testing programs of new and existing products. This
procedure is focused on setting up of stability programs, testing, reporting, general sampling procedure for stability programs, data generation
and analysis, annual maintenance of stability, new product stability procedure, procedure for in-house trials, reporting and interpretation of trials
and conclusion of the trail program.
Microbiology (Sterility) Laboratory Procedures

In this area you will find Standard Operating Procedures on Entry Procedure to Sterile Filling Areas, Validation of Aseptic Gowning Procedures,
Microbiological Data Recording Procedure, Destruction of Biological Waste in the Microbiology Laboratory, Depyrogenation of Glassware In
Micro. Lab. Oven, Media Preparation in Microbiology Laboratory, Aseptic Media Filling and Micro. Integrity Leak (Soup) Testing Procedure,
Aseptic Media Filling and Soup Test Guideline, Environmental and Plant Hygene Monitoring Procedure, Microbial Limit Testing Procedure by
Using Laminar Flow Cabinets etc and many other procedures according to your need.

All procedures have reference of prepared Forms and Templates for effective record keeping and reporting purposes. Forms are attached at
the end of each procedure. Templates are listed separately.

SOP List

Sterile Entry
This SOP outlines the gowning procedure that must be followed by each and every person who enters a Sterile Area. The procedure is
designed to reduce the risk of contaminating product with bacteria and/or particles

Aseptic Gowning Validation


Aseptic gowning is the ability to complete the gowning procedure without compromising the sterility of the garment. This SOP outlines the
sterile gowning validation procedure as required for the final sign off for the initial sterile training and the revalidation of currently trained
Operators, Fitters, Electricians and Cleaners and all organization staff who are authorized to enter Sterile areas.

Microbiological Data Recording


To describe procedures for the recording of Microbiological data using the in-house hard copy and computerized recording system. All
documents containing test results are legal documents and therefore it is imperative that all the information required is recorded accurately. Any
changes/corrections to be made must be signed with that person’s initials and dated.
Biological Waste Destruction
To describe procedures for destroying all Laboratory Biological Waste to comply with Quarantine Regulations

Depyrogenation of Glassware
To outline the procedure for the depyrogenation of glassware using the Microbiology Laboratory Qualtex Oven.

Media Preparation
To describe the procedures for the preparation of microbiological media for use in the Microbiology Laboratory.

Micro. Integrity Leak (Soup) Testing


One of the requirements of cGMP is a periodic evaluation of all aseptic processes by filling media into the appropriate containers under normal
production conditions. The media fill should reflect the sterility of the entire process from the Sterilizing filter to the filled primary container and
should include all subsequent manufacturing steps. This SOP outlines the procedures for both Media Fills and Microbiological Leak Tests. For
Validation purposes, a Microbiological Leak Test (Soup test) or a separate Protocol to verify the entire process from the ‘Bioburden Reduction
Filter’ to the primary container may be required.

Aseptic Media Filling and Soup Test


Media Fills are designed to verify the entire process, equipment and staff. This process simulation should be performed as initial validation with
three (3) consecutive satisfactory simulation tests per shift and repeated at defined 6 monthly intervals (twice per year per process per shift)
and after any significant modification to the HVAC-system, equipment, process and number of shifts” for aseptically filled process. Soup test
has to be conducted at least once per year per shift for terminally sterilised lines and non-sterile process. Validation and re-validation media fills
are to assure the sterility of the entire process. This process simulation test should imitate as closely as possible the routine aseptic
manufacturing process and include all the critical subsequent manufacturing steps. The Media Fill should challenge the “worst case” situation
and should include all the possible interventions of a normal production run. The duration of the media run should be at least 4 hours or half a
production shift to allow for all routine interventions.

Environmental and Plant Hygiene Monitoring


Description for Microbiological testing of areas of the environment which may influence or affect product performance and/or quality-including,
air, surfaces, personnel, clothing and disinfectants. Daily monitoring of sterile grade areas during production is to be conducted by trained
production staff. The Microlab is to ensure that the necessary plates are delivered on a daily basis so monitoring can take place. Once a test
has been completed, the responsible operator is to initial the plate and make sure that the batch number of the batch running at the time of the
test is written on the plate. Plates will be labeled with prompts to ensure this isn’t forgotten. If no batch is running at the time of the test N/A
should be put on the plate instead of a batch number. If an area of concern is noted during routine daily testing, inform Micro immediately so
that further steps can be taken.

Microbial Limit Testing Using Laminar Flow Cabinets.


To describe the procedures to be followed in conducting Microbial Limit Tests in the Laminar flow Cabinets in the Microbiology Lab.

Microbiological Monitoring of Plant Water Systems


In this SOP you will find Sampling Procedure for Bioburden and Endotoxin Samples, Bioburden Test Method and Results, Endotoxin Testing of
WFI (Distilled Water), Bioburden and Bacterial Endotoxin Alert and Action Levels, Diagrammatic Representations of a typical purified Water
Systems, Bioburden Waste Tank Water Sampling, Clean Steam Sampling & Testing, OOL/OOS Result Actions etc

Sterility Testing Procedure


This sop is to describe the procedure for sterility testing of aqueous, injectable and terminally sterilized non injectable products. To explain the
correct interpretation of sterility results and to outline Stasis requirements for used sterility canisters.

Determination of Heat Resistance of Spore Forming Organisms


This SOP describes the method for calculating the Heat Resistance Factor, (D-value),of spore-forming organisms. D-Value is defined as the
time required for a population of a pure culture of microorganisms to be decreased by 90% when exposed to a fixed temperature, e.g. 121°C
(+1°C).

Identification of Microorganisms to Genus and Species Level


To describe the procedures for the preliminary identification of bacteria isolated from Plant Water, Environmental, Personnel, Product and Raw
Material sources. Bacteria that will require identification (ID) to at least genus level include organisms isolated from the manufacturing
environment, personnel, in-process and finished products, plant water and other miscellaneous sources. SOP’s detailing the microbiological
testing procedures for each of these samples will indicate the required level of ID of recovered organisms. The following sections detail the
procedures for the preliminary ID of micro-organisms. Further ID to species level is to be conducted for conformation.

Micro Evaluation on Bioburden, Non sterile and Raw Materials


This SOP describes the procedures for Microbiological Evaluation of Bioburdens, non-sterile Products & raw materials. Bioburdens includes:
Batches prior to membrane filtration, i.e. solutions; Batches prior to sterilization i.e. filled containers; Face masks; IPA. This procedure includes
Equipment preparation for Non-sterile testing, Bulk Solution Bioburden (BSB) Sampling; Filled Container Bioburdens (FCB); Raw Material
Bioburden (RMB); Surgical Face Masks; Isopropyl Alcohol (70% IPA); Speciation Procedures for Organisms found in Non Sterile Products and
Raw Materials; Out-of-Specification Procedures for Non Sterile Products and Raw Materials; Retest and Repeat Procedures for Non-Sterile
Products and Raw Materials.
Bacterial Endo Toxin Testing (LAL) - Gel Clot Method
To describe the procedure for conducting a Bacterial Endotoxin Test by the LAL Gel-Clot method. The gel-clot method for bacterial endotoxin
testing described in this SOP is based on the fact that Limulus Amoebocyte Lysate (LAL) will form a firm gel in the presence of bacterial
endotoxin.

Bacterial Endo Toxin Testing kCA Method


The purpose of this SOP is to outline the theory of Bacterial Endotoxin testing using Kinetic Chromogenic Analysis (KCA). And to outline the
procedure for routine product testing, operator / reagent verification and product validation by KCA using the BioWhittaker KQCL (brand)
reader. This Procedure also describes the routine maintenance procedures for the BioWhittaker KQCL (brand) reader.

Stock Suspension of Micro Organism


The objective of this SOP is: To describe the method for preparing and maintaining stock suspensions of vegetative microorganisms and
spores used within the Microbiology Laborator;. To explain the procedure for growth promotion and media verification requirements for all
media used within the Laboratory; To outline requirements for Stasis testing on sterility canisters after sterility testing has been completed.

Sterile Sampling Procedure for Microbiology Laboratory


To detail the procedure for taking Microbiological samples for Sterility testing, Bacterial Endotoxin testing, Bioassay testing, Microbial Limit test
and Micro status testing throughout Production. This procedure includes sterilization charts, Settle plates (Fallout plates) and Personnel
monitoring.

Gel Clot Validation Method


The gel clot validation method for Bacterial Endotoxin testing described in this SOP, is to determine the level of Inhibition/Enhancement of
products on the LAL test for endotoxins within the allowable Maximum Valid Dilution (MVD) for each type of product. The Gel-Clot techniques
detect or quantify endotoxins based on clotting of the LAL reagent in the presence of endotoxin. To be determined for each type of product,
using the highest and lowest concentration of active. If either concentration shows inhibition or enhancement, then each remaining
concentration must be tested. At least three (3) Production batches of each finished product should be tested for inhibition and enhancement.

Laboratory Investigation for Atypical and OOS Results


The purpose of this procedure is to provide guidance when investigating microbiology laboratory out of specification (OOS) results associated
with raw material samples, in-process samples and finished product samples. This procedure describes the actions taken by Microbiology
Laboratory staff in the event the result of a test does not conform to company specifications for microbiological release. This procedure will also
provide guidance for re-testing raw material samples, in-process samples and finished product samples when it has been decided through a
laboratory investigation that retesting is justified. Retesting should be viewed as an investigational tool to aid in determination of the root cause
of the discrepant laboratory result.

Contamination Testing Procedure


To describe the test sometimes used to check the purity of the IPA used in the factory as a disinfectant.

Process, Cleaning and Methodology Validation Procedures

In this area you will find procedures on validation-concept and procedure, revalidation procedure, method validation procedure, procedure for
cleaning validation, validation of laboratory instruments, equipment specification and qualification and in-house trial procedure.

All procedures have reference of prepared Forms and Templates for effective record keeping and reporting purposes. Forms are attached at
the end of each procedure. Templates are listed separately.

SOP list

Concept and Procedure of Validation


This procedure describes general validation concepts and practices, the way processes and systems must be qualified/validated and the
confirmatory documentation required. Here you will find the philosophy of validation, responsibilities, validation approaches of design
qualification, installation qualification, operational qualification, performance qualification, cleaning validation, method validation, computer
validation, general and specific criteria of validation, validation documentation and change control, validation reporting, guidelines of validation
acceptance criteria.

Revalidation
This procedure contains step by step instruction on initiation of revalidation categories, changes that warrant revalidation programs, basic steps
of revalidation procedure, revalidation activities and specific responsibilities, revalidation protocols, revalidation timing, equipment checklist,
revalidation discrepancy procedure, release of revalidated equipment, preparation of the revalidation reporting file.

Method Validation
This procedure provides a guideline for a validation Technician on the characteristics that must be considered during the validation of an
analytical testing procedure. The procedures set out in this SOP apply to qualitative and quantitative analytical methods which are used to test
finished goods, in-process material, excipients and raw materials in support of registration documentation and cleaning validations and
management responsibilities towards completing those method validation tasks.
Cleaning Validation
This SOP describes the types of cleaning process and cleaning agents of process equipments and their validation, complete instruction on
cleaning validation procedure, calculation of acceptance limits for rinse and swab samples, calculation of acceptance limits for swabs, analytical
method validation for cleaning, cleaning validation test protocols and change control for revalidation.

Validation of Laboratory Instruments


This procedure describes the validation practices for laboratory instrument/equipment to be validated or calibrated and the confirmatory
documentation required showing that the instrument/equipment is capable and operating effectively for its intended purpose. This procedure
has practical instruction on Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to be performed by
the qualified equipment service technician in the presence of the laboratory staff with reference to the instrument/equipment manual.

Equipment Specification and Qualification


This procedure describes in detail the procedures for the procurement of equipment, incorporating standardized demand specifications and
Installation Qualification documentation, to ensure that equipment procured complies with in-house requirements and standards and conform to
Good Engineering Practice, to detail the general procedure to be followed regarding the reporting of Factory and Site Acceptance Tests, to
detail the manner by which the equipment Installation Qualification is documented.

In-House Trial
The purpose of this SOP is to define common procedures to follow when organizing Trials/Evaluation Studies for the purpose of process
improvement, equipment capability and validation studies. It defines the responsibilities within the trial process and documents that need to be
considered when preparing the Trial documentation to ensure that the trial meets GMP and where applicable validation requirements. This SOP
defines the procedures for conducting in house stand-alone trials on systems, processes and equipment. There can be an overlap between a
trial and validation in that Trial documentation may form part of a latter process validation, (i.e. concurrent and prospective validation) and
qualifications (OQ, PQ).

Computerized Systems Validation


To overview the procedure to be followed for the Qualification/Validation of computerized systems. This procedure applies to all computer
systems (including embedded systems) directly associated with, or supporting, regulatory compliance requirements for the development,
testing, manufacture and distribution of medicinal products.

Impact Assessment for Computerized Systems


The purpose of this SOP is to provide a method of assessing and determining the validation requirements for computerized systems and
controllers. The SOP identifies the typical qualification activities required for those systems having a Direct or Indirect impact on
product/process quality and data integrity, should the system fail or malfunction. These activities are in addition to Good Engineering Practice
(GEP), which is appropriate for all systems, and is also outlined

Functional Testing Guide for Computerized System


This SOP provides guidance on functional testing during the development or change of computerized systems which have GxP impact at a
GMP manufacturing site. What constitutes a change to a computerized system is described in manufacturing change control procedure.

Design Qualification Guidelines


The purpose of this document is to provide guidelines on conducting Design Qualification (DQ) during the conceptual and detail design phase
for the implementation of a GMP facility, process and equipment (including computerized systems) to ensure conformance to operational and
regulatory expectations. The guideline will provide the basis for conducting and documenting Design Qualification to all projects involving the
introduction of, or significant change to, any facility, system or equipment that potentially impacts on product quality and is suitable for its
intended purpose.

Protecting the Reliability of Electronic GMP Records


This SOP applies to records created, processed, used or stored by (or for) the GMP Manufacturing site, that are the output of a computerized
system. It is of particular relevance to records that have a GMP role, i.e. supporting product quality, patient safety or regulatory compliance.
The guideline may also be used for other computerized systems that are classified as business critical.

GMP | Manufacturing Procedures

In this area you will find exciting procedures on Clothing Requirements Inside the Factory Area, Cleaning Responsibilities and Methods for
Employees, Factory Cleaning Procedure, Manufacturing Pest Control, Tours of Factory, Requirements of Production Logbook, Packaging
Configuration for Production Line, Checking of Components Prior to Use, Tag Out Procedure, Procedures for Line Clearance, Line Opening
and Line Cleaning, Reconciliation of Component and Product, Operation of Barcode Reader as an example, Intermediate Bulk Container (IBC)
Operation and Cleaning, Tablet Packing Machine and Cartoner-construction, operation and cleaning as an example, Manufacturing Instruction
for Tablet Packing as an example, Mop Cleaning Procedure, Scheduling Production Lines, Vacuum Leak Testing Procedure, Weighing
Equipment - Checking and Calibration, Operation of Checkweigher as an example, Tablet Packing-Start up and In-process Testing as an
example, Packed Tablet Sampling by Production Personnel for Testing as an example

All procedures have reference of prepared Forms and Visual Displays for effective record keeping and reporting purposes. Forms are attached
at the end of each procedure.

SOP list
Clothing Requirements
This SOP covers the clothing requirements needed in all Factory areas for your manufacturing site. The different levels of cleanliness must be
maintained to minimize microbial and particle contamination. This procedure contains general rules and restriction to be followed by your
manufacturing employees, defining different environmentally graded areas and entry requirements for those areas.

Cleaning Responsibilities and Methods


This SOP describes the cleaning procedures to be followed by all employees working in the manufacturing area in order to prevent
contamination of product by foreign materials from another batch, or by dirty parts, which may contain bacteria. This SOP contains instruction
on responsibility of cleaning, degree of cleaning to be done, popular cleaning aids and solutions permitted to use for cleaning, rubbish removal
and outline of cleaning methods for different environmentally graded areas.

Factory Cleaning
This SOP defines the methods, frequency and the intensity of Factory Cleaning. The purpose of cleaning is to remove debris from within the
plant in a sanitary and effective manner and to avoid contamination from dust or foreign materials. This procedure describes which popular
cleaning aids and solutions are to be used to clean the floors, walls, sinks and windows in the Production areas, office areas, change rooms,
workshops, laboratories, stores, canteens, plus the toilet facilities. This procedure also describes the scope and responsibility of contract
cleaners.

Manufacturing Pest Control


This SOP describes the responsibilities of all employees and pest control services, classification of pests, frequency of the pest control service
and effective treatments against all types of pest.

Production Logbook
This procedure outlines the generation, maintenance and filing of Production logbooks. Production logbooks form part of the documentation
system required by the Code of GMP to provide complete and up-to-date histories of all batches of product. The logbook provides a key link in
the process of traceability.

Packaging Configuration for Production Line


This SOP provides an alphabetically indexed diagram of shipper packing and pallet packing configurations for any packaging process. This
procedure contains schematic diagrams of different packaging configurations and calculations of total unit to be packed per container which can
be useable into your packing lines.

Checking of Components before Use


This SOP sets out a procedure to ensure that only components of correct code and batch number are issued for a batch and only issued
components will be used in a finished product batch. This SOP also describes the procedure to be followed during returning of components to
warehouse from the production lines.

Tag Out Procedure


This SOP describes how to prevent the risk of personal injury or damage to equipment likely to be caused by operating or attempting to operate
machinery or equipment diagnosed as being unsafe, in need of repair or maintenance or formally removed from service. The SOP covers all
isolation, condemning, repair or maintenance work that necessitates a device or machine to be taken out of service. This SOP applies to any
situation where energy (either supplied to equipment, or stored within it) needs to be isolated to ensure the safety of any person working on or
near equipment, processes or services - for any reason whatsoever.

Line Clearance, Line Opening and Line Cleaning


This SOP describes the procedure and order to be followed when performing a Line clearance, Line opening and Line cleaning for a batch
production. The procedure has been established to prevent mix-ups of products, containers, components, labels and mistakes in
documentations. Mix-ups and mistakes can occur when correct procedure and GMP are not followed. Particular care should be taken when
starting a new operation, at the change of shift and when additional components are needed. In this procedure you will find example of line
clearance, opening and cleaning checklist based on an example of tablet packing line.

Reconciliation of Component and Product


This simple SOP describes the concept of reconciliation, how to reconcile finished goods and determine the allowable discrepancies of
components and products when reconciled.

Construction, Operation and Cleaning of Tablet Packing Machine


This procedure describes the machine construction and operation, machine start up and cleaning of a typical tablet Blistering machine and the
Cartoner for tablet packing. You will be able to create a new procedure for your packing line based on the format of this SOP.

Manufacturing Instruction for Packing


This procedure describes how to create a complete manufacturing instruction for your process line to be followed by your manufacturing
employees. To make the instruction more practical and easy to understand, a sample instruction is added in the form of a protocol for a typical
tablet packing process. All the related blank forms are attached at the end of the procedure for a better understanding.

Mop Cleaning
This simple procedure outlines the operation of the factory laundry in a safe and hazard-free manner. This procedure can be used in any
manufacturing site for the purpose of mop cleaning.
Scheduling of Production Lines
This procedure describes how to produce a monthly manufacturing schedule following an agreed 12 months plan, to provide a sequence of
work that will enable the scheduling of support groups (i.e. Quality, Technical and Warehousing), incorporate any planned engineering down
time (i.e. project work, calibration and preventative maintenance), create and release batches according to the agreed weekly schedule, provide
key dates for product supply to support Customer Service.

Vacuum Leak Testing Procedure


This SOP describes the set up and operation of a standard vacuum Leak Tester for the very popular vacuum leak testing used in a typical
packing line.

Tablet Packing-Start up and In-process Testing


This procedure contains instructions that enable the production operators working in a typical packing line to carry out Start-Up and In-Process
Tests required in order to produce quality products and to ensure in-process controls. A typical tablet packing process is used here as an
example.

Finished Product Sampling for Testing


This procedure describes the process of sampling manufactured finished good required to be taken by production personnel for the laboratory
testing. A typical tablet packing process is used here as an example.

Warehouse Management Procedures

In this area you will find procedures on Receipt of Incoming Goods, Raw Material and Components-Incoming-Handling by Sampler, procedure
for Warehouse to Processing Issues, Returns and Rejects, Dispatch of Goods from Warehouse, Warehouse Inventory Management,
Warehouse Locations and Storage Area, Finished Goods Transfer to Quarantine and Distribution Warehouse, Sampling of Raw Materials,
Sampling of Components and Printed Materials, Work in Progress Area, Safety Procedure of Warehouse Racking, Forklift Operation in
Warehouse, Tablet Dispensary Procedure as an example, Raw Material Tablet Sampling by Dispensary as an example, Material Purchasing
Information Record and Source List, Generation of Purchase Order For Inventory and Consumables

SOP List

Incoming Goods
This SOP contains step by step instruction on condition of accepting incoming goods in the warehouse, ‘booking In’ procedure of component
and non component goods, how to complete movements of incoming goods into different storage locations within the warehouse maintaining
full traceability. Here you will find generation and filing of documents related to receipt of incoming goods.

In-coming Raw Material and Components Handling


This procedure describes quarantining, sampling, testing and releasing of incoming raw materials to Production. Here you will find the labeling
requirement for component to be sampled, checking requirements of components, sampling and re-sampling of incoming goods for laboratory
testing, generation of documentation during the movement of components in order to maintain complete traceability.

Processing Issues Return and Rejects


This SOP contains step by step instruction on issue of tested and QC released components for batch production, documentation needed for
capturing identification and traceability information during the picking, assembling and transferring of those components from warehouse to
production. This procedure also has instruction to follow during the return and reject processing of raw materials and components from
production to warehouse.

Dispatch of Goods from Warehouse


This SOP contains instruction and documentation on movement of finished goods to quarantine until release for sale, dispatching procedure
and documentation needed for transferring of finished goods from quarantine to warehouse store and subsequently to out side the
manufacturing site maintaining a complete traceability of finished goods.

Inventory Management
In this procedure you will find a complete inventory management system by stock counting instruction, stock classification and reconciliation
programs. Here you will find instruction on cycle counting by material code, counting by bin sheet information and reconciling/cross checking of
those counts by physical counting of the stock, determination of material gain or loss and filing instruction.

Warehouse Locations and Storage Area


This SOP is designed to understand and draw an schematic diagram of ideal warehouse and production areas, identifying in-coming goods
storage unit types and storage bin types, quarantines, reject cage, cool room, flammable storage, dispensary booths, production area, finished
goods quarantine area and finished goods storage areas. This procedure defines how storage unit types and storage bins are numbered. This
SOP is to be used as a guide to define the types of storage units and bins, movement direction within the warehouse and production areas.

Finished Goods Transfers to areas


This simple SOP contains instruction and documentation on movement of finished goods from production to warehouse finished goods
quarantine location until the samples are tested and released by the authorized persons.

Sampling of Raw Materials


This procedure primarily concerned with risk associated with sampling, precaution to be followed when sampling, general sampling procedures
for raw materials, critical and non critical components, chemicals and secondary reference standards for laboratory.
Sampling of Components and Printed Materials
This procedure is an elaboration of SOP WAR-045 and mainly concerned with sampling plans and instructions of components and printed
materials for quality testing before release for production use.

Work in Progress
This simple procedure describes the construction and locations of different work in progress areas between production and warehouse for
temporary storage of raw materials, component and finished goods.

Warehouse Racking
This SOP outlines the measures to be taken to ensure the safety of all goods and personnel when using the storage racking system in order to
avoid injury to staff or damage to property. This procedure concerned with the handling and storage of materials or products and to report any
damage which may be occurred. This SOP particularly relates to the activities of the staff of the receiving and distribution warehouse.

Forklift Operation in Warehouse


This SOP gives instructions on operation requirements and maintenance of forklifts used in the warehouse, safety precaution to be taken during
the operation of forklift under load.

Dispensary Procedure
This procedure is mainly concerned with dispensing plans and instructions of released raw materials for production use. An example of tablet
dispensary procedure is prepared for better explanation and understandings of dispensing. You will be able to follow the instruction for
dispensing of any raw materials in your facility.

Material Purchasing Information Record


This simple procedure describes how to keep purchasing information for approved materials, vendors, manufacturers, standard and current
pricing and third party agreements.

Generation of Purchase Order


This procedure describes the steps to be followed by planning and procurement department to create purchase order for inventory items to be
purchased from overseas and local suppliers.

Quality Guidance
Validation of Analytical Test Methods
This guideline provides guidance for the validation of analytical test methods. These analytical test methods include those tests which evaluate
API, Raw Materials, In Process samples (e.g. reaction monitoring) and early intermediate materials (prior to the introduction of the first critical
intermediate). This also include Risk Assessment and Prioritization, System Suitability, Precision and Accuracy, Quantitation and Detection
Limit
Linearity, Range and Specificity, Robustness,

Calculations of Residue Limits for Drug Product for Equipment Cleaning


This guideline provides equations and examples for calculating the Maximum Allowable Residue and Residue Acceptability Limits for Drug
Products and Non-Therapeutics. Examples are provided for determining the acceptable equipment cleaning residue limits for therapeutic drug
products and for non-therapeutic ingredients.

Swab Sampling for API Equipment


This guidance provides recommendations related to the selection and application of swab sampling and visual inspection for various types of
API equipment.

Product and Equipment Grouping and Worst - Case Product Selection


This procedure defines the criteria that should be considered when grouping Active Pharmaceutical Ingredient (API) and Drug Product (DP)
equipment or product for the purposes of cleaning validation.

Validation of Test Method for Rinsate and Swab Sample


The guidance describes recommended approaches to develop and validate sampling and test methods for cleaning verification using rinse and
swab samples.

Visual Inspection and Quantitation in Equipment Cleaning


Visual inspection is the minimum requirement for all clean and test regimes required for Cleaning and Cleaning Validation. Five aspects of
visual inspection discussed in this guidance. Which are visual inspection following or during manual cleaning; visual inspection of dedicated
equipment; routine visual inspection of multi-purpose equipment; visual inspection during validation and Visual Quantitation

Documentation and Instruction in Cleaning Validation


14 This guidance addresses recommendations for developing and documenting the rationale to support the product contact equipment cleaning
program and to justify the validation strategy. This documentation may be described as a Cleaning Evaluation Report.

Critical Process Parameters for Drug Product


This guidance provides recommendations and examples for evaluating a process to identify and define the critical process parameters.
Identification of the Critical Steps for Drug Manufacturing Process
This guidance provides recommendations for selecting critical process parameters and critical process steps based on the understanding of a
drug product process.

Equipment Cleaning Validation for API


This procedure provides guidance in the validation of cleaning processes for equipment used in the manufacture of Active Pharmaceutical
Ingredients (API).

Equivalence Criteria of Impurities in API Process Validation


This guidance provides recommendations for demonstrating equivalence of impurities to historic batches during validation of API processes for
small molecules.

Equivalency Comparison of Drug Product


This guidance addresses the equivalency comparison of manufacturing process data from drug product (DP) validation batches to previous
batches (called “reference” batches), when applicable.

Calculation of Clean Equipment Hold Times


This guidance describes considerations and risks for determining if the establishment of clean equipment hold times for equipment producing
drug product and Active Pharmaceutical Ingredients (API) are required

Potential Impact of Changes in Process Validation


This guidance provides recommendations and examples for evaluating the process validation impact of changes to manufacturing processes
used for manufacture of API, Drug Products and packaging processes.

Process Validation Sampling


This guidance addresses recommendations for good sampling practices. Validation sampling plans must be specified or referenced in the
protocol.

Determination of Swab & Visual Inspection Sampling Locations


This guidance provides recommendations related to the selection and application of swab sampling and visual inspection for various types of
Drug Product equipment.

Bulk Drug Product Holding Times


This Guidance sets out guidelines for the determination and validation of in-process and bulk product holding times.

Continuous Quality Verification


This guidance provides an example of documentation to support the use of Continuous Quality Verification for demonstrating that a
manufacturing process is in a validated state.

Dose & Toxicity Data for Cleaning Limit Calculation


This guidance provides points to consider when selecting Dosage and Toxicity data for use in the Cleaning Limits calculations.

Inspection Attributes in Non Sterile Packaging Validation


This procedure provides examples and guidance on classification of defects for packaged non-sterile drug products.

Laboratory Instrument Qualification


This procedure provides guidance in the qualification of simple, moderate, and complex laboratory equipment that is used in an analytical
laboratory in a Good Manufacturing Practices (GMP) environment associated with products in or intended for the market place.

Matrices and Bracketing in Process Validation


Bracketing and matrixing allow a ‘most appropriate challenge’ condition to be defined for a process or drug product family (the same drug
product with different dosage strengths). This risk-based approach can allow the validation to be focused on the most challenging
circumstances, or “worst cases.” Use of this approach can provide a significant benefit to reduce the overall validation effort.

Potential Critical Process Parameters and Validation Practices


This Guidance provides a tabulation of potential critical process parameters and quality attributes of typical steps of primary solid drug product
(i.e. dry products) packaging processes. It also includes packaging validation items such as evaluation of equipment, protocol and report
contents, amount of data (e.g. number of runs) and if warranted, microbiological studies.

Process Validation Sampling for Non-Sterile Liquid Semi Solid Drug Products
This guidance provides Process Validation Sampling guidelines for non-sterile liquid (solutions and suspensions) and semi-solid (ointments,
creams, pastes, gels and lotions) drug product dosage forms.

Process Validation Sampling for Non-Sterile Solid Dose Drug Products


This guidance provides Process Validation Sampling guidelines for non-sterile solid dose drug product dosage forms. The purpose of this
guidance is to provide the general principles and approaches that should be considered for sampling non-sterile solid dosage forms.
Periodic Review of Processes and Systems
This guidance addresses the application of a risk-based approach to: Prioritize the systems and processes for periodic review (PR); Justify
frequency and schedule of PR (if applicable); Routine revalidation of processes.
Selection of Critical Process Parameters for Validation
This guidance discusses the term critical process parameter and considerations are described for identifying the term CPP that need validation.
It is applicable to the manufacture of commercial intermediates, API, Drug Products and packaging.

Solvent Recovery Validation Example


This guidance provides an example of the documentation for validation of a solvent recovery process. Solvent recovery validation is needed in
some situations such as where the recovered solvent is intended for general site wide reuse into suitable manufacturing processes, including
other API manufacturing processes than those from which the used solvent originated

Test Deviations during Validation


Out-of-specification (OOS) results and any other deviations that may impact the acceptability of the qualification/validation should be
documented, investigated, root cause determined, corrective action taken and reported. Several examples are included.

Validation Documentation
This guidance provides recommendations for the content of the planning, testing and reporting types of validation documentation.

Product Quality Complaint Handling


This Complaint Handling guidance defines practices for establishing and maintaining a product quality complaint handling system, and for
monitoring and reporting corrective actions based on the findings

Application of Quality Risk Management to Periodic Review of SOPs


Application of Quality Risk Management to Periodic Review of SOPs is intended to provide a tool for determining the optimal review frequency
that will ensure those SOPs which relate to GMP systems or processes and therefore bear the greatest potential for impact on product quality
are reviewed/revised in a timely and possibly more frequent manner than those which are determined to be less critical or reflect stable
processes.

Statistical Rationale for Raw Material Sampling


The practice of using the √N+1 as a rule for sample size is common in the pharmaceutical industry.

Structured On-the-Job Training System


This document discusses considerations for a site Structured On-the-Job Training system including GMP tasks and knowledge necessary to
perform those tasks.

Quality Assurance Audit


This document provides guidance in the conduct of Quality Assurance Audits to verify and assure the effectiveness of on-going quality systems,
practices and programs and to identify potential procedural gaps or system weaknesses at Manufacturing Production and logistic Sites.

Annual Product Records Review


This document provides guidance in the performance of annual product record reviews to evaluate data and trending to: Verify consistency of
the process; Identify the need to modify specifications, and Identify any preventive or corrective actions that would lead to product quality
improvements.

Material Supplier Approval


This document provides guidance in the process for identifying suppliers to be audited and the process for conducting and documenting such
audits and approving suppliers.

Storage & Distribution of Drug Products and Medical Devices


This document provides guidance the storage and distribution requirements for Drug Products, Medical Devices and related Production
Materials from a GMP Site or Logistics Centers, and/or transported between manufacturing and Logistic Sites.

Pest Control
This document provides guidance in the implementation and maintenance of pest control program for buildings and facilities at a GMP Site and
Logistics Centers that are used for production, testing, or storage of pharmaceutical ingredients.

Water Purification, Storage and Distribution for Pharmaceutical Production


This document provides guidance for the purification, storage and distribution of water used for Production including water used for cleaning of
product contact equipment, containers, and closures.

Reduced Testing Program


This guidance document defines a science and risk-based approach for the evaluation and
implementation of a reduced testing program for the release of starting materials, intermediates, APIs, excipients and packaging components at
a GMP user site upon receipt from vendors (manufacturer/supplier). The guidance also provides an example of the application of Quality Risk
Management principles in the implementation of a reduced testing program.

Stability Testing
This document provides guidance for the stability testing for drug products, consumer non-drug products (e.g., cosmetics), Active
Pharmaceutical Ingredients (API), API Intermediates for Sale and medical devices manufactured at GMP facilities.
Implementation of Real Time Release
This document provides practical guidance on how to implement a Real Time Release (RTR) testing approach as part of a manufacturing
control strategy to ensure product quality while enabling the rapid release of API, intermediate and/or finished products.

Preventive Maintenance
This document provides guidance in for Preventive Maintenance of direct impact systems and associated critical components used in
production, storage, and testing that may affect the safety, identity, strength, quality, or purity of active pharmaceutical ingredients, drug
products, drug product raw materials, API starting materials, critical in-process materials, critical intermediates, biologics, or medical devices.

Analytical Laboratory Management


This document provides guidance for the management of analytical laboratories including the following: Personnel training; Proper handling of
samples; Hazardous materials; Control and maintenance of reagents, reference standards, and buffers; Laboratory facilities and equipment;
and Documentation and control of test results.

Microbiology Laboratory Management


This document provides guidance for the management of microbiology laboratories including the following: Proper handling of samples; Control
and maintenance of reagents, reference standards, buffers, microbial cultures, and microbiological culture media; Monitoring and control of the
microbiology laboratory environment; Calibration and maintenance of laboratory equipment; and Documentation and control of microbiological
test results.

Quality Agreements
This document provides general guidance to site Quality Teams responsible for writing, revision and maintenance of Quality Agreements with
suppliers of materials.

Clean Steam Systems


This document provides guidance for clean steam used in aseptic applications, and applications where the steam or condensate directly
contacts products or materials, or direct product contact surfaces (i.e., equipment, containers, closures).

Cleaning and Sterilization of Aseptic Manufacturing Equipment


This document provides guidance in the cleaning and sterilization of aseptic manufacturing equipment to minimize the risk of particulate and
microbiological contamination.

Container Closure Integrity for Sterile Drug Products


This document provides guidance for ensuring that the integrity of the container closure system will protect the product over its shelf life.

Controlling the Microbiological Quality of Solid Oral Dosage Forms


To control the microbial quality of a non-sterile Solid Oral Dosage form, it is recommended to perform a risk assessment of the manufacturing
process to identify potential sources of microbial contamination. The intention of this document is to provide guidance to determine and control
these sources of microbial contamination.

Evaluation of Repeat Testing and Retesting During Microbiological OOS Investigation


During a laboratory investigation, confusion may arise as to the difference between these terms and their overall purpose. This document
provides a more detailed explanation of these differences and the individual importance of these tools during a
Microbiological OOS laboratory investigation. In addition, this guidance will also briefly clarify similarities and differences of these definitions as
compared to analytical OOS laboratory investigations.

Microbiological Testing in Cleaning Validation


This document describes the rationale and recommended microbiological methodology for consideration during cleaning validation of product
contact surfaces for Active Pharmaceutical Ingredients (APIs) and drug products.

Overview of Trending of Environmental Monitoring Data


This guidance establishes the need for trending of environmental monitoring data and gives recommendations on aspects of trending such as
categorization of data, frequency of trending, trend definition, and content of trend reports.

Cross Contamination Prevention


This document provides guidance for the prevention of cross contamination in production processes, warehousing, material transfer, and
distribution.

Water Activity in Pharmaceutical Manufacturing


This document discusses the basic principles of water activity and the importance it has in the manufacture of pharmaceuticals. It also provides
direction on when and where testing for water activity can be most beneficial.

Quality Manuals

Retention and Disposal of GMP Documents and Retention Samples


The purpose of this procedure is to describe the minimum requirements for the retention of samples and documents under GMP and Medical
Device regulations/legislation. Local legislative and regulatory requirements which may require retention of increased sample quantities or
longer retention periods, take precedence over this procedure.
Certificate of Materials Supplied
This guideline aims to define the processes for certification of materials provided by suppliers including the requirements for maintaining
materials in a “certified“ status for use.

Procedure for Quality Assurance Management for Contractors


The purpose of this Procedure is to describe the requirements for the quality management of contractors; to describe the role of contract giver
sites in this context and to provide a model for the development of Quality Assurance Agreements with Contractors

Regulatory Inspection Guideline


To provide the minimum mandatory requirements for notification, conduct, reporting and follow-up action associated with inspections by
regulatory authorities and also to outline recommendations on how to achieve compliance.

Compliance Improvements Plans for GMP Facility


The purpose of this document is to provide some requirements as well as some recommendations for the development, content and
management of Compliance Improvement Plans (CIPs).

Archiving, Disposal and Record Management Guideline


The purpose of this document is to provide management and technical personnel with requirements as well as guidance on the archiving,
records management and disposal of data and information.

Audit of a Distribution Site for Medicinal Products


This Procedure defines the procedure for performing Distribution Site audits and includes selecting, preparing for, conducting, reporting and
documentation archiving of Distribution Site audits.

Supplier Auditing for GMP Facility


This manual is to provide guidance on assigning Lead Audit Team/Site responsibilities, establishing an external supplier’s audit program, and
the high level principles involved inconducting supplier audits.

Management and Control of Master GMP Document


The purpose of this Guideline is to provide the regulatory requirements for the management of master GMP documents; issued, controlled and
used to verify compliance with required codes of GMP and/or other relevant Quality and Compliance Standards. Recommendations are also
included on how to achieve compliance

Artwork Creation & Control of Printed Packaging Components


The purpose of this Guideline is to describe the way in which artworks and printed package components should be created and controlled.

Definition and Documentation of Raw Data


The purpose of this Guideline is to provide requirements in the definition and documentation of raw data and also to outline recommendations
on how to achieve compliance.

Risk Management in the Quality Assurance and Compliance Area


The purpose of this document is to give guidance on a process for risk identification, assessment, control and review within the area of GxP
regulated quality and compliance.

Guideline for Development and Contents of Specifications


The purpose of this guideline is to describe the process for generation, approval and management within R&D of specifications for release of
materials used in clinical trials during drug development. It also gives guidance on the contents of such specifications for drug substance,
several common types of investigational medicinal products and excipients.

Determination of Storage Periods for APIs, Excipients, Intermediates and Raw Materials
The purpose of this Procedure is to define the requirements for the retesting and assignment of storage periods for API’s, excipients,
intermediates and raw materials.

The Preparation of Process Validation Master Plan


This procedure covers the planning of validation activities related to the manufacturing and control of the registered stages of Drug Product or
Active Pharmaceutical Ingredient (API) for clinical use, validation or sale.

Process Validation of Bulk Medicinal (API and Intermediate)


The purpose of this document is to provide guidance on the validation of processes for the manufacture of bulk drug i.e. those synthetic stages
from introduction of the defined API Starting Materials into the process up to and including the physical processing of the API (Active
Pharmaceutical Ingredient). Validation should extend to those operations determined to be critical to the quality and purity of the API. The
validation of stages prior to the API Starting Materials is not mandatory. A risk assessment may deem it necessary.

Process Validation for Formulated Products


The purpose of this document is to provide minimum mandatory requirements in the validation of processes for the commercial manufacture of
formulated products to demonstrate the effectiveness and reproducibility of a process and being suitable for the intended purpose. The purpose
is also to outline recommendation on how to achieve compliance.

Cleaning and Cleaning Validation of API Plant and Equipment


The purpose of this guideline is: To define the requirements for cleaning plant and equipment used to manufacture active pharmaceutical
ingredients (APIs) or their intermediates; To give guidance on how to assure appropriate cleaning of API plants and equipment; To describe
when validation is applicable and what must be done to complete validation.

Cleaning and Cleaning Validation For Formulated Products


The Purpose of this guideline is to define the minimum requirements for cleaning and validation of cleaning processes for formulated product. It
also covers post validation monitoring of the effectiveness of cleaning processes.

Sterilization Process Validation


To provide guidelines for the validation of sterilization processes used in the manufacturing activities for drug products or active Pharmaceutical
ingredients (API) and also to outline recommendations on how to achieve compliance.

Analytical Laboratory Procedure Validation


The purpose of this guideline is to outline the content and approval process for analytical procedures, and to describe those activities that
should be carried out to demonstrate that analytical procedures used in laboratories within R&D and manufacturing operations are suitable for
their intended purpose.

Water Quality Standard


To describe the quality standards required for the production, distribution, use and testing of water used in the manufacture of manufactured
materials.

Sterility Testing Procedure


The purpose of this Guideline is to provide a general guideline for sterility testing. This guideline should aid in assuring that the products
manufactured at the company’s sites as well as by a contract manufacturers meet the appropriate regulatory and company requirements and
that there is a harmonized, company-wide approach to the concept of sterility testing.

Storage and Expiry Dating of Analytical Reagents in Laboratory


The purpose of this Guideline is to outline the requirements in the expiration dating of all analytical reagents and solutions prepared from these
reagents. Recommendations are also included on how to achieve compliance.

Preparation & Maintenance of Stability Protocols and Stability Master Plans


The purpose of this document is to describe the procedure for the preparation and management of Stability Protocols and Stability Master
Plans for marketed products and Drug Substances.

Microbiological Testing for Non Sterile Medicinal Product


The purpose of this Guideline is to provide guidance for the microbiological testing of non-sterile products. This guideline should aid in assuring
that the products manufactured at each of the gmp sites as well as by a contract manufacturer should meet the appropriate regulatory and
company requirements and that there is a standardized, company-wide approach to the basic concept of microbiological quality control of non-
sterile products.

Reference & Retention Samples


The purpose of this guideline is to describe the requirements for the sampling and storage of reference and retention samples under GMP
regulations/legislation. Local regulatory requirements that require the retention of additional samples, increased sample quantities or longer
retention periods, take precedence over this guideline.

Commercial Stability Testing For Formulated Products


The intent of this procedure is to provide to manufacturing and primary packaging sites the principles of a stability program.

Environmental Monitoring
The purpose of this Guideline is to provide requirements for environmental monitoring. This guideline provides recommendations on how to
achieve compliance with the requirements. This guideline will aid in assuring that the commercial and investigational medicinal products
manufactured will meet the appropriate regulatory and company requirements.

Trending of Stability Data


The purpose of this international guideline is to outline minimum mandatory requirements as well as recommendations for the identification and
reaction to trends found in stability data

Manufacturing Documentation
This document provides guidelines for the way in which the commercial manufacture and packaging of Active Pharmaceutical Ingredients (API)
and formulated drug products should be documented.

Maintenance and Calibration of GMP Critical Items in Manufacturing Operations


The purpose of this guideline is to define the general requirements and to provide guidance for the calibration and maintenance of instruments,
equipment, facilities, utilities/services and systems.

Re-treatment and Blending of API & Formulated Product


The purpose of this guideline is to provide guidance regarding the reworking, reprocessing or recovery (salvaging) of formulated products,
active pharmaceutical ingredients (API’s) and intermediates used in the processing of APIs.
In-Process Testing, Checks and Sampling
The purpose of this International Guideline is to describe the requirements for in-process testing and sampling during manufacture and packing.

Management of Returned Goods


The purpose of this International Guideline is to describe the principle of handling the quality assessment and recovery of returned goods.

Management of Change in Manufacturing Operations


The purpose of this procedure is to define the principles for management of change within Operations. This document may applies to the
Change Management process, to Regulatory Affairs, CMC and to all cGMP activities performed by an Operation sites. It applies to all facilities,
processes, systems and procedures used during manufacture, testing and distribution that may directly or indirectly affect the quality of
pharmaceuticals products.
.
The Validation of Facilities and Systems
The purpose of this guideline is to provide requirements for the Validation of Facilities and Systems and to outline recommendations on how to
achieve compliance.

Information Technology Infrastructure Qualification


This Guideline provides guidance on the qualification requirements to be applied to the Information Technology infrastructure. The
establishment and maintenance of a qualified infrastructure for any regulated company is fundamental to meeting current business and
regulatory requirements in respect of systems stability, reliability and security.

Management of Change in Computerized System


The purpose of this Guideline is to define and provide guidance on the requirements for managing and documenting changes which take place
during the development, implementation or operation of a computerized system, including its supporting operating environment.

Access by Regulatory Authorities and Auditors to Electronic Records


The purpose of this Guideline is to advise on the practices to be adopted when wishing or requested, to display or provide copies of electronic
records to regulatory authorities, auditors and other similar third parties.

Guidelines for Generating Manufacturing Documentations


This document provides guidelines for the way in which the commercial manufacture and packaging of Active Pharmaceutical Ingredients (API)
and formulated drug products should be documented.

Electronic Records and Electronic Signatures


The purpose of this document is to provide an interpretation of FDA 21 CFR Part 11, Electronic Records; Electronic Signatures (ER/ES) and to
provide guidance for acceptable practices in the use of electronic records and electronic signatures by any site.

GMP Audit

Auditing Principles for GMP Audit, Understanding Worldwide Regulatory Requirements, Personnel & Training System Audit, Deviation
Management System Audit, Validation System Audit, Change Management System Audit, Complaint System Audit, Documentation System
Audit, Calibration/ Preventative Maintenance & Housekeeping System Audit, Computerized Systems Audit, Utility Systems Audit, Warehouse
and Distribution System Audit, Environmental Monitoring System Audit, Microbiology and Sterility Testing Laboratory Audit, Analytical Quality &
Stability Testing Laboratory Audit, Material Handling System Audit, Active API Manufacturer Audit, Packaging Material Supplier Audit

Quality Templates

Raw Material Specification and Test Report Template, Internal Audit Report Template, Training Report Template, Form Template, SOP
Template, Quality Assurance Agreement Template, Third Party Manufacture Dispatch Report Template, In-House Manual Template, Rework
Protocol for Manufactured Finished Goods, Vendor Assurance and Audit Report Template, Rework Protocol for Work in Progress Goods,
Position Paper Template, Laboratory Control Method Template, Product Formulation Template, Finished Product Specification and Test Report
Template, Packaging Material Specification and Test Report, Bill of Materials Template

Validation Templates

Cleaning Validation-Rinsing Test Template, Cleaning Validation-Swab Test Template, Cleaning Validation-Comparative Analysis Template,
Example of Installation Qualification Report, Example of Operatio
nal Qualification Report, Example of Operational Qualification Test Protocol, Example of Performance Qualification Test Protocol, Example of
Validation Plan, Example of Validation Report, Example of User Requirement Specification, Example of Commissioning Plan, Example of
Design Qualification Protocol, Example of Installation Qualification Equipment, Example of Installation Qualification HVAC, Example of
Installation Qualification Operating Environment, Example of Installation Qualification Pipe-work, Example of Installation Qualification Utilities,
Example of Electrical Demand Specification, Example of Instrumentation Demand Specification, Example of Mechanical Demand Specification,
Example of HAZOP Report, Example of Traceability Matrix Report, Example of Validation Discrepancy Form, Example of Validation Report
Combined OQ_PQ, Example of Project Definition Report, Example of Project Evaluation and Closeout Report, Example of Test Protocol
Change Request Form, Example of Installation Qualification Computer, Cleaning Validation Interim Report Template, Cleaning Validation
Campaign Length Increase Protocol, Cleaning Validation Protocol Template, Cleaning Validation Report Template, Installation and Operational
Qualification Protocol Template, Installation and Operational Qualification Report Template, Packaging Validation Protocol Template,
Packaging Validation Report Template, Process Validation Protocol template, Process Validation Report Template, Process Validation Report
Template-pdf links, Product Transfer Protocol Template, Electronic Records and Signatures Compliance Assessment, Impact Assessment
Template for Equipment, Utility and Computer
Abid Ali Khan
B.Z.U. Multan, Pakistan

khanbpharm@gmail.com
Mobile: +923346103393

Jamson Pharmaceuticals Pvt. Ltd.


88-A Industrial Estate Multan, Pakistan