Roll no: 49

Assignment Of: Pharmaceutical Quality

Management
Topic: Good Manufacturing practices &
Current Good Manufacturing practices
Submitted TO: Sir Umar Jan Agha
University of Balochistan
Quetta

Date: ____________________
Remarks: ____________________

Sign of Teacher: _________________

Chapter 11 According to HEC Revised Syllabus 2013 as;

11. STANDARDIZATION OF PHARMACEUTICALS: An understanding of quality

assurance system adopted in pharmaceutical industry. Good Manufacturing Practices and
Current Good Manufacturing Practices.

Good Manufacturing Practices and

Current Good Manufacturing Practices:
DEFINITION:
Good manufacturing practices (GMP) are the practices required in
order to conform to the guidelines recommended by agencies that control
the authorization and licensing of the manufacture & sale
of food and beverages, cosmetics, pharmaceutical products, dietary
supplements, and medical devices.
Explanation:
These guidelines provide minimum requirements that a
manufacturer must meet to assure that their products are consistently high
in quality, from batch to batch, for their intended use. The rules that govern
each industry may differ significantly; however, the main purpose of GMP is
always to prevent harm from occurring to the end user. Additional tenets
include ensuring the end product is free from contamination, that it is
consistent in its manufacture, that its manufacture has been well
documented, that personnel are well trained, and the product has been
checked for quality more than just at the end phase. GMP is typically
ensured through the effective use of a quality management system (QMS).
Good manufacturing practices, along with good agricultural practices, good
laboratory practices and good clinical practices, are overseen by regulatory
agencies & Authorities.
Good Manufacturing Practice is concerned with both production and
quality control. The basic requirements of GMP are that:
a) All manufacturing processes are clearly defined, systematically reviewed
in the light of experience and shown to be capable of consistently
manufacturing medicinal products of the required quality and complying
with their specifications and/or marketing authorization;
b) Critical steps of manufacturing processes and significant changes to the
process are validated;
c) All necessary facilities for GMP are provided including:
i. Appropriately qualified and trained personnel;
ii. Adequate premises and space;
iii. Suitable equipment and services;
iv. Correct materials, containers and labels;
v. approved procedures and instructions;
d) Instructions and procedures are written in an instructional form in clear
and
Unambiguous language, specifically applicable to the facilities provided;
e) Operators are trained to carry out procedures correctly;
f) Records are made, manually and/or by recording instruments, during
manufacture which demonstrate that all the steps required by the defined
procedures and instructions were in fact taken and that the quantity and
quality of the product was as expected. Any significant deviations are fully
recorded and investigated;
g) Records of manufacture including distribution which enable the
complete history of a batch to be traced, are retained in a comprehensible
and accessible form;
h) The distribution (wholesaling) of the products minimizes any risk to
their quality;
i) A system is available to recall any batch of product, from sale or supply;
j) Complaints about marketed products are examined, the causes of quality
defects
Investigated and appropriate measures taken in respect of the defective
products and to prevent re-occurrence.
CGMP (Current Good Manufacturing Practices) establishes a quality
control unit having authority and responsibility to approve or reject drug
products. Basic units of CGMP are:
1. Buildings
2. Sanitation
3. Equipments
4. Personnel
5. Materials
6. Record
7. Master Production & Control Record
8. Quality Assurance
9. Quality Control & Pharmaceutical Control
10. Quality Review
1. Buildings:
CGMP requires buildings to be:
 Suitable size, construction and location to facilitate adequate
cleaning, maintenance and proper operations.
 Adequate Space for proper operations, orderly placements of
equipment and storage of products.
 Storage for Packaging, Manufacturing and processing
operations.
 Area for Control laboratories
 Designing must be as such that Floors and walls can be easily
cleaned and free of contamination.
 System for cleaning and disinfecting the room and equipment.
 Adequate lighting, ventilation, screening, air pressure.
 Microorganisms, dust, humidity and temperature controlling
systems.
2. Sanitation:
Sanitation programs and procedures should be
documented in written and kept in records with periodic review
concerning performance and compliance. There must be a
nomination for the responsible person for sanitation program. CGMP
includes:
 Use of insecticides and pesticides must not contaminate the
materials and equipment.
 Adequate washing facilities with hot and cold water.
 Soap/Detergents, Air driers or service towels and clean toilet
facilities must be available.
 Areas for food, beverages, lunch or breakfast must be specified and
controlled.
 Dustbins or trash bins must be provided.
 Drains must be of adequate size with traps to prevent backflow.
 Special provisions must be made to dispose of sewage, trash and
other refuse from building and premises.
3. Equipment:
Equipments used in processing, packaging, labelling,
holding and testing of drugs shall be of suitable size, type and
accuracy.
CGMP includes:
 Such Equipments shall be used which are not reactive, additive
or absorptive to alter drug characteristics.
  Equipment shall facilitate adjustment, disassembly, cleaning
and maintenance to assure reliability and uniformity of
production.
 Equipments must be cleaned and sanitized periodically to
avoid malfunction and contamination.
 Use of precise automatic mechanical or electronic equipment
in production is appreciated.
 Computer system can be used to check proper input and
output.
4. Personnel:
Personnel responsible for supervision shall be adequate
in number. Personnel must have education, training or experience to
perform their assigned functions. They must assure that the drug has
safety, strength, quality and purity. CGMP includes:
 Training must be given to new appointees
 Personnel working in manufacturing must wear neat and clean
clothing and protective apparel.
 Personnel must have good sanitation and health habits.
 Company must provide periodic health examinations of
employees.
 Personnel must be updated/informed of the new facilities by
the company.
5. Materials:
Following protocols are followed in CGMP:
 Materials must be stored or handled in such a way to avoid
contamination, splashes and spills.
 Written procedures must be followed in receiving, storage,
sampling, testing and approval or rejection of components,
containers or closures.
 All materials imported must be tested for conformance with
established specifications.
 Each component must be physically, visually and chemically
examined.
 From each lot of bulk (raw materials) samples shall be taken
and examined.
 Prior to sampling containers must be clean, sterile and
pyrogen free.
 Samples must be labelled to show the name, lot number, date
and Name of sampler.
 Raw Material Labels
_________ _____

______

 Containers of sample must not be reactive, additive or

absorptive.
 Written standards for materials storage, packaging and
utilizing must be provided to the concerned personnel.
6. Record:
Records for components shall be maintained. Records
must
 Include the identity and quality of the component,
 Name of supplier
 Lot number
 Date of Receipt.
 Result of examination and tests.
 Its use in each batch of Drug product.
It is advisable to Reserve samples of all active ingredients
except excipients.
7. Master Production and Control Record:
To assure uniformity in drug production from batch to
batch a master production record must be kept for each and every
product separately. Which must be dated, signed and inspected by
the competent and responsible individual or authority. The master
production and record for products must include:
 Name
 Strength of the product
 Description of Dosage from
 Labels
 Name and weight of active ingredient per dosage unit
 List of all ingredients with weight.
 Description of container, closure and packaging.
  An actual copy of currently used labels is placed in this
master file.

This master record must be compared or reviewed periodically at various

stages of processing. To assure uniformity and validate manufacturing
Quality control in-process tests must be performed. Batch production and
record must be prepared for each batch of drug produced. Laboratory tests
must be performed for every active ingredient of product and then
labelling operations must be continued and adequate to assure that only
those products that have met standards and specifications shall be
distributed.
8. Quality Assurance
Overall objective of the QA is to insure that each product
leaving the plant for consumer distribution has met every
recommendations of the current good manufacturing practices. The
product has been:
 Maintained within the identity
 Purity
 Potency
 Quality Standards
Throughout the Manufacturing and packaging operations and made
fit for the purpose.
9. Quality Control & Pharmaceutical Functions:
QC deals with several basic functions, CGMP, manufacturing
audits, in-process controls, label control, formula control, and over all
compliance to final release. This unit performs many functions
including:
 Raw material testing and analysis
 Release or rejection of raw material of production use
 In-process testing of manufactured items
 Finished pharmaceutical testing & analysis
 Issuance of final analytical release
 Maintenance of Quality assurance
 Packaging release
 Labels and labelling
 Manufacturing Batch records
 Administration of good manufacturing practices
 Validation studies & Maintenance of records
 Maintenance of
 Analytical files
 Batch Record Files
  Label And labelling files
 Master file record
This field also look after for
i. Microbiological and biological control:
Many pharmaceuticals require complete
sterile environment and products are completely
sterilized and free of contamination. CGMP includes the
look after of such departments by periodic or random
testing and analysis. This department is responsible for
sterile products like ophthalmic preparations, injectable
preparations and potency testing for antibiotics etc.
ii. Analytical control and development
It performs the following broad areas of
responsibility
 Analytical method evaluation
 Analytical method development
 Stability Studies
 Special technical problems
The responsibility for maintaining a
complete stability profile on every marketed
product usually falls within the area of analytical
and developmental control by checking physical
parameters such as color, ph, viscosity, surface
tension and hardness, stability dates or expiration
dates, etc.
10. Quality Review
It is necessary to continually evaluate current analytical
methodologies like HPLC, UV & IR spectroscopy, etc. for better
performance and more accurate results. Quality review performs
annual in-depth inspection of each manufacturing and quality control
department to insure compliance with CGMP’s standard operating
procedures and commitments made as a result of regulatory
authorities’ inspection.
 DEPARTMENT OF PHARMACY
NAME:-------------Farhaad Noor

Roll no: --------------26

Assignment of: ---PHARMACEUTICAL Quality Control
TOPIC: ----- Standardization of Pharmaceuticals

Teacher: ------Sir Umar Jan Agha

Checked by:____________
Date:____________
Remarks____________
 STANDARDIZATION OF PHARMACEUTICALS AND
FORMULATED PRODUCTS:
The word standardization is derived from the word standard which implies to
some major principle or model with which things of the same class are
compared in order to determine quality or value. In pharmaceuticals standards
are of two types:
Standards which are given in the pharmacopeia in the form of monograph

Standards which are framed by the manufacturer

1. OBJECTIVE OF STANDARDIZATION:
The prime objective of standardization is that the chemical substances or
formulated products must be clinically satisfactory this means it should be
safe, effective and stable and it shouldn’t have any unspecified variation in its
amount and it is free from any toxicity or harmful effect.

2. STANDARDIZATION PROCESS:
In the standardization process various test and assay procedure are applied for
the evaluation of raw material, processed, intermediate and finished products
so as to confirm these compliance with the standard. For this it is necessary to
have a good knowledge of the methods and procedure. As discussed earlier
that for standardization the substances or formulated product must adhere to
the approved standards and it is a possibility that two different types of
standards may differ from one another and therefore, it is necessary that
certain variation limits are established. In the standardization process the
following are taken into account;

• NATURE AND PURITY OF RAW MATERIALS AND FINISHED

PRODUCTS:
The raw materials are standardize by ascertaining various characteristics these
include purity, identity, strength, and detection of contaminants, all of these
are determined by melting pint, boiling point, specific gravity, UV-visible
spectrophotometry, NMR etc.

➢ MANUFACTURING VARIATIONS:
As we know that different drugs are prepared by different manufacturer under
different environmental and physical conditions and therefore, it is necessary
that there must be a minimum standard for a given pharmaceutical
formulation. Usually the percent error allowed is ± 5%.

➢ HAZARDS OF STORAGE:
During storage there are chances that the drug may undergo decomposition
and loss of the active ingredient. In order to provide the exact amount of drug
to the consumer, in some cases it becomes necessary ti incorporate overages
into the product so that it may complies with the accurate amount. It is
therefore, necessary that standard must maintain the overages. Here it must
be remembered that these overages can only be incorporated in those cases
where they do not cause any harm or toxicity to the patients.

➢ CONDITIONS OF USE:
The official standards must take into account the conditions under which the
product is likely to be used, different geographical conditions influence the
product in different ways and therefore, ICH (International Conference of
Harmonization) has bifurcated the world into four zones and has provided
different set of conditions for standardization, preservation, storage etc and
drug prepared in respective zone must comply with these standards.

➢ DOSAGE FORM AND PACKAGING:

The standard must provide criteria for the dosage form with reference to its
packaging i.e. packaging material and also it should provide specifications for
preservation.