QUALITY MANUAL

GOOD MANUFACTURING PRACTICES

ISO 22716:2007

DHABE HERBALS PRIVATE LIMITED

ADDRESS: SHOREA 32, JETVAN COLONY, SAI COMPOUND, NEAR GOGA BABA TEMPLE
NEAR OPEN GYM, CHH. SAMBHAJINAGAR (AURANGABAD) 431002
MO. 9923700222, Email: dhabeherbals@gmail.com

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 INDEX

SR. NO. PARTICULARS PAGE NO

1 Title, Purpose and Scope 3

2 Abbreviation 4
3 Quality Policy 5

4 Quality Objective 6
5 Introduction to the Manual 7
6 Introduction to the Organization 8
7 GMP ISO Standards 12
8 PDCA Cycle 14
9 Quality Systems 15
10 GMP ISO Management System 17
11 Aspects of ISO Implementation 20
12 Good Manufacturing Practice System 23
Documentation
13 Management Responsibility 25
14 Resource Management 30

15 Planning and Realization of Safe Products 32

16 Validation, Verification and Improvement of 41
Good Manufacturing Practice System

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TITLE, PURPOSE AND SCOPE

TITLE: Good Manufacturing Practices Systems Manual

PURPOSE: This Good Manufacturing Practice GMP ISO 22716:2007 Manual and related
to Quality Management System document referred there in are intended for the
purpose of Implementation of GMP ISO 22716:2007 of Dhabe Herbals Private Limited.

REGISTERED OFFICE:

Shorea 32, Jetvan Colony, Sai Compund, Near Goga Baba Temple, Near Open gym, Chh.
Sambhajinagar (Aurangabad)

SCOPE: Research Development, Training, Consultancy of Herbal, Ayurvedic, Natural,

Organic, Cosmetics Products and to Manufacture, Repack, Retail, Wholesale, Trade,
Export sof Ayura Herbal Face Pack, Ayura Herbal Black Henna, Ayura Herbal Brown
Henna, Ayura Herbal Hair Wash, Ayura Herbal Wax Powder, Ayura Herbal Utane, Ayura
Herbal Handmade Soaps, Ayura Herbal Aloevera Gel, Ayura Natural Henna, Massage Oil,
Herbal Hair oil, Herbal Massage Oil (pain oil), Abhyang Snaan Oil, Herbal Shampoo, Kajal,
Lip Balm, DTan Face pack, Foot Crack Cream, Pigmentation Cream, Magical Face
Powder, Face Cream, Face Cleanser, Scrub, Sunscreen, Herbal Healing Oil, Clay Pack,
Herbal Lipsticks, Herbal Lotions.

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ABBRIVATION

DHA- Dhabe Herbals Private Limited

DIR - Director
ST- Standard
TL - Team Leader
MKT - Marketing
PUR- purchase
INC – In-charge
ADMIN - Administration
MRM - Management Review Meeting
IQA- Internal Quality Audits
HOD- Head of the Department
Q- Quality
QC- Quality Control
QA — Quality Assurance
PRO- Production
R - Responsibility
A - Authority
Rev - Revision
Doc - Document
No. - Number
TC — Test certificate
SSP Safety System procedure
WI- Work instruction
Dept- Department
CH- Chart

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QUALITY POLICY

We at Dhabe Herbals Private Limited take considerable pride in developing,

sustaining unsurpassed levels of quality in manufacturing of Herbal Cosmetics
products in order to meet customer satisfaction.

Our Quality Comprises of:

1) Manufacturing and supplying excellent quality of Herbal Cosmetics

products to consistently meet the needs of esteemed clients and the
mankind in general.
2) Ensuring strict compliances with ISO guidelines, prevailing national and
international standards in accordance with Herbal Cosmetics products
Manufacturing Industry.
3) Treating health, Safety and environmental protection as an Integral part of
the quality strategy.
4) Enhancing customer satisfaction through continuous improvement of
Quality Management System in conformity with GMP ISO 22716:2007

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QUALITY OBJECTIVES

The aim of this certification is to define the appropriate quality standards

applicable for the Herbal Cosmetics products manufacturing, when
implemented t h a t will allow manufacturers to operate robust, modern
quality systems.

The objectives are:

 Propose a model example of a quality system for a
manufacturing of Herbal Cosmetics products Products.
 Determine the feasibility of implementation such a
system for the Herbal Cosmetics products
Manufacturing.
 Explore the benefits of implementing such a system in
Herbal Cosmetics products manufacturing.

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INTRODUCTION TO THE MANUAL

This Good Manufacturing Practice is prepared to address the requirements of the

International Standard GMP ISO 22716:2007. This Quality System manual forms a part
of overall Quality Management System being implemented by Dhabe Herbals Private
Limited.

The purposes of this manual and related Good Manufacturing Practice Safety System
documents, the definitions given in GMP ISO 22716:2007 shall apply.

Dhabe Herbals Private Limited has developed this Safety manual in order to implement
Good Manufacturing Practice System in accordance with the international standard
GMP ISO 22716:2007. This manual addresses all elements in GMP ISO 22716:2007 and
outlines the structure of documentation used in the GMP Safety System. It describes or
makes reference to the GMP safety system procedures, according to which the respective
functions carry out its activities in a systematic and effective manner in order to,
achieve the safety Policy and objectives of the organization.

Good Manufacturing Practice manual document reference number and revision status is
identified in page (1). This GMP safety manual is prepared by the Team Leader and
approved by the Director in accordance with the requirements of GMP ISO
22716:2007.

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INTRODUCTION TO THE ORGANIZATION

Dhabe Herbals Private Limited is one of the leading manufacturing units of Herbal
Cosmetics products operated at Chh. Sambhajinagar. We are Manufacturers of Ayura
Herbal Face Pack, Ayura Herbal Black Henna, Ayura Herbal Brown Henna, Ayura Herbal
Hair Wash, Ayura Herbal Wax Powder, Ayura Herbal Utane, Ayura Herbal Handmade
Soaps, Ayura Herbal Aloe vera Gel, Ayura Natural Henna, Massage Oil, Herbal Hair oil,
Herbal Massage Oil (pain oil), Abhyang Snaan Oil, Herbal Shampoo, Kajal, Lip Balm, DTan
Face pack, Foot Crack Cream, Pigmentation Cream, Magical Face Powder, Face Cream,
Face Cleanser, Scrub, Sunscreen, Herbal Healing Oil, Clay Pack, Herbal Lipsticks, Herbal
Lotions.

DIRECTOR INFORMATION

1) Mrs. Archana Arvind Dhabe

1. Post held : Director, Dhabe Herbals Pvt. Ltd., Aurangabad

2. Date of Birth : 30/09/1978
3. Educational Qualifications : B. Sc. (Botany, Chemistry, Microbiology)
: P G Diploma in Fermentation, Distillery and Wine
Technology
: Ayurved Vaidya Visharad (AVV)

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 : ND (Diploma in Naturopathy)
4. Trainings Completed : “How to start your own Business/ Startup”
conducted by MCED, Aurangabad

: “Process and Product Standardization” conducted by

MCED, Aurangabad
5. Activities : Manufacturing and selling Homemade Herbal
Powders Herbal Cosmetics, Herbal Nutraceuticals at small scale.
6. Participated in Exhibitions : Aurangabad Municipal Corporation,
Cum sales organized by : Maha Agro, Dept
of Agriculture, Govt. of Maharashtra
: Maharashtra Khadi & Gramodyog Mandal,
Aurangabad
: Magnet Exhibition cum Sale, Aurangabad
: Diwali Festival Shoppe, Aurangabad
: Kharedi Yatra, Aurangabad
7. Address : 32, Shorea, Jetvan Colony, SAI Compound, Near
Gogababa Temple, Near Open Gym,
Chh. Sambhajinagar (Aurangabad)
8. Mobile : +91 9923700222
9. Email : archanaarvinddhabe@gmailcom

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Miss. Ayura Arvind Dhabe

Bachelor’s of Pharmacy (2020-Present)

Government College of Pharmacy, Chhatrapati Sambhajinagar (Aurangabad)
Dr. Babasaheb Ambedkar Marathwada University, Chhatrapati Sambhajinagar
(Aurangabad)
Average SGPA: 8.21
Core Modules: Pharmaceutics, Pharmacology, Organic and Medicinal Chemistry,
Formulative and Industrial Pharmacy, Pharmacognosy and Phytochemistry,
Pharmaceutical Analysis, Biopharmaceutics, and Quality Assurance
• Higher Secondary Certification (HSC) (2020)Kendriya
Vidyalaya Aurangabad Percentage Score: 78.2 %
Core Modules: Chemistry, Physics, Biology and Math
• Secondary School Certification (SSC) (2018)
Kendriya Vidyalaya Aurangabad Percentage Score: 86%
In Plant Trainee: (Sept 2023- Oct 2023) : Lupin Limited
Patent application No. 202321060874, titled "Poly Herbal Decoction for Treating Acute
Respiratory Disease Caused by Novel Corona virus," filed with the Patent Office,
Mumbai, and published in Oct 2023.
Publications:
• Pundge R. S., Dhabe A. A., Dongre S. V. ,Maraskole I. M., and Dhabe A. S.
“Phytochemical Analysis of Alysicarpus scariosus Graham”. Bioinfolet. V 20. No. 3
B. (2023): 629 -632.

• Dhabe A. A., Shekade P. P., Chavan S. S. and Dhabe A. S. “Poly Herbal Formulation
(IB01) For the Treatment of Severe Acute Respiratory Syndrome Caused By Novel
Corona Virus SARS-CoV-2 “ Manuscript submitted for Publication.

Awards and Achievement:

• Awarded 1st prize for an article titled 'Pharmacist Strengthening Health System:
Organ Donation' in celebration of World Pharmacist Day.

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 • Qualified GPAT (Graduate Pharmacy Aptitude Test) conducted by National Testing
Agency, 2023.
• Qualified GATE (Graduate Aptitude Test in Engineering - Life Sciences) conducted
by Indian Institute of Technology (IIT) Kanpur, 2023.
• Awarded 1st Prize in research paper presentation at National Conference on
Bioresources 2023, on the topic ‘Efficacy of anti-COVID-19 herbal decoction’.
• 89.91 Percentile in MHT-CET conducted by National Testing Agency (NTA), 2020.

Skills:
• Research - Investigating/researching, collecting data, and generating insights into
pharmaceutical practices
• Communication- Effective oral and written communication, able to convey ideas
clearly
• Leadership- Organizing, Coordinating, and Managing multiple responsibilities
• Public speaking- Experienced in delivering presentations and engaging audiences
through effective public speaking techniques
• Problem-Solving- Critical thinking, analyzing, and decision making

Vision statement of Dhabe Herbals Private Limited is to become India’s one of largest
manufacturer of Herbal Cosmetics products and retail, wholesale, E-commerce
distribution platform dealing in these products which are entirely made in India using
natural herbal ingredients and having eco-friendly in nature.

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GMP ISO STANDARDS

This ISO standard is the benchmark in cosmetics GMP. ISO 22716 certification helps
businesses identify and mitigate the risks associated with production that can impact
product safety and quality. As its name implies, GMP allows organizations to
demonstrate their commitment to safeguarding the quality and safety of their finished
cosmetics products.

GMP is the first step in cosmetics compliance, providing a comprehensive approach for
quality management. It assures that the way a product is designed, formulated,
manufactured, packaged, stored, and shipped is achieved safely, hygienically, and
responsibly.

The success of all cosmetics businesses relies heavily on its capacity to produce
effective, safe, high quality, and reputable cosmetic products. Understanding the
fundamentals of GMP is extremely beneficial, addressing one of the most important
aspects of cosmetics manufacturing: To protect consumers by enhancing cosmetic
product safety across all elements of the supply chain.

ISO 22716:2007 is the international standard for the good manufacturing practices
(GMP) for cosmetics. The guidelines for the standard has been approved and accepted
by a many global regulatory bodies, such as the International Cooperation on Cosmetics
Regulation (ICCR), Food & Drug Administration (FDA) and the European Committee for
Standardisation (CEN).
The ISO 22716:2007 standard has been prepared for consideration by the cosmetic
industry and take into account the specific needs of this sector. The standard focuses on
the production, control, storage and shipment of cosmetic products. These guidelines
offer organizational and practical advice on the management of the human, technical
and administrative factors affecting product quality.

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Good manufacturing practices (GMP) are essential to any organization looking to reduce
the risk and liability of their cosmetics products that can result from poor handling
within their operation.
ISO 22716 introduces a management systems approach to documenting and regulating
the production, control, storage, and shipment of cosmetic products. The standard’s
guidelines will provide your organization with practical methods for managing the many
factors that can affect product quality.

This ISO standard is the benchmark in cosmetics GMP, the certification of ISO 22716
helps businesses identify and mitigate the risks associated with production that can
impact product safety and quality. As its name implies, GMP allows organizations to
demonstrate their commitment to safeguarding the quality and safety of their finished
cosmetics products. It is the first step in cosmetics compliance, providing a
comprehensive approach for quality management to make sure the way a product is
designed, formulated, manufactured, packaged, stored, and shipped is achieved safely,
hygienically, and responsibly. The success of all cosmetics businesses relies heavily on its
capacity to produce effective, safe, high quality, and reputable cosmetic products.
Understanding the fundamentals of GMP can be extremely beneficial and is one of the
most important aspects of cosmetics manufacturing, to enhance the safety of consumer
cosmetic products across all elements of the supply chain and to protect the consumer.

Quality refers to the stability of a cosmetic product, its preservation, and its overall
function. Many of the tests that are required check that the quality of a product remains
to a high standard, any products containing water are at risk of contamination of
microbial growth and will require sampled quality checks to ensure a product remains
stable and passes challenge tests. For sampling and testing purposes, samples must be
identifiable by their name, concentration, expiration date, opening date, storage
conditions, and the name of the person who prepared them. The samples should be
taken in sufficient sizes so that any local regulatory bodies could undertake analysis on
them if required.

The GMP for cosmetics ISO 22716 requirement but may be a legal requirement as part
of the cosmetics regulations. All complaints should be centrally recorded using a
systematic complaint logging and review process, investigating complaints should
include the steps to prevent a product defect from reoccurring, recognizing potential
issues with safety or quality. If a severe or high-risk safety or quality issue is suspected, a
company must be capable of implementing a product recall quickly and efficiently.

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PDCA CYCLE

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GOOD MANUFACTURING PRACTICES
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QUALITY SYSTEMS

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QUALITY MANAGEMENT

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GMP ISO MANAGEMENT SYSTEM

General
Dhabe Herbals Private Limited established, documented, implemented and maintains a
Good Manufacturing Practice System and continually improves its effectiveness in
accordance with the requirements of the International Standard GMP ISO 22716:2007.

To implement the Good Manufacturing Practice System, Dhabe Herbals Private Limited has,
a) Identified the processes needed for the Good Manufacturing Practice System
and their application throughout the organization,
b) Determined the sequence and interaction of these processes.
c) Evaluate Periodically, and update when necessary, the Good Manufacturing Practice
system to ensure that the system reflects the organization‘s activities and incorporates
the most recent information on the safety hazards subject to control.
d) Determined criteria and methods needed to ensure that both the operation and
control of these processes are effective (detailed in various clauses of FMS and GMP
safety System procedures).
e) Ensured the availability of resources and information necessary to support the
operation and monitoring of these processes.
Systems to monitor measure and analyze these processes and instructions.

ISO 22716:2007 is the international standard for Good Manufacturing Practices

(GMP) for cosmetics. The cosmetic industry has considered the ISO 22716 standard
and the specific needs of this sector. The standard focuses on production. Control,
storage, and shipment of cosmetic products. These guidelines offer organizational
and practical advice on managing the human, technical and administrative factors

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 affecting product quality.
Good manufacturing practices (GMP) are essential to any organization looking to reduce
the risk and ability of their cosmetic product that can result from poor handling within
their operation. ISO 22716 guides several areas, which can be broadly divided into 5
categories:

 Personnel
 Premises and equipment
 Production
 Quality control
 Quality systems
ISO 22716 also has direct links to many other cosmetic regulations in place around the
world. Regulators in several countries and regions have adopted this standard.

GMP can contribute to the quality of products overall by,

 Prove the organization’s management capabilities in product quality and safety

assurance.
 Enable employees to develop good production/operations habits.
 Reduce safety risks in product quality and safety.
 Timely detect production and management problems and reduce cost. Operating
costs drop as rework and penalties because non-compliance reduces and
efficiencies increase… increasing profits.
 Increased potential for economic growth and development.
 The critical steps of the manufacturing process should be validated to ensure
they meet specific GMP qualification guidelines.
 Regular reviews of this process will also help to ensure that product quality
remains high and consistent.
 Improvement in overall performance & compliance
 Identify & Control hazards & risks associated with product
 Customers satisfaction
 Comply with regulatory requirements
 Increased efficiency and cost saving
 Helpful to enroll as a vendor for retail stores
 Globally accepted standard
 Helpful in alluring new customers
 Helpful to retain the confidence of existing customers
 Acceptable for International organizations

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The focus will be on GMPs, the central pillar of the cosmetic regulatory framework, and
ISO 22716- Cosmetic standard on GMP and quality aspects for cosmetics. Good
Manufacturing Practice Requirements include:

 Facility design, construction, layout and product flow, product handling, packing
and storage, waste management, Pest Control, Transport, and Personal Hygiene.
 Issues on traceability and ensuring that the ingredients used for producing the
final products are traceable and respect the standards set for cosmetic products
shall be highlighted.

ISO 22716 standard can benefit both customers and businesses:

 Helps to ensure quality and safety compliance throughout every stage of the
supply chain. This leads to a better final product while ensuring a safe
environment for employees.

 Reduces the potential hazards of cosmetics manufacturing and promotes better

manufacturing practices to protect employees and also the environment.

 Supports legal compliance from international regulators, allowing businesses to

create products and serve them to a variety of markets while adhering to local
regulations.

 Promotes continuous improvement in operations through an internal auditing

system that quickly identifies and resolves problems to ensure a smooth
manufacturing process.

 Helps establish a comprehensive system to deal with product deviations,

complaints, and recalls.
 It systematically provides how to document and regulate the production,
manage, storage and shipment of cosmetic products in order to identify and
prevent risks that may affect product quality in advance.
 The worldwide cosmetics market is showing high growth rates every year, and
interest in cosmetics manufacturing and quality management are also increasing
as cosmetics are closely related to consumers' health and skin.
 Many countries require a high level of manufacturing and quality control, and the
importance of quality and safety is also being emphasized due to issues related to
the safety and harmfulness of cosmetics.

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ASPECTS OF ISO IMPLEMENTATION

1) Key responsibilities:
Key roles, responsibilities, authorities for personnel are assigned, communicated,
understood and that personnel receive relevant Good Manufacturing Practices as per
the standard operating procedure (SOP-01-Personnel and Training). Dhabe Herbals Pvt.
Ltd. employs only staff who has the required technical, skill, experience and education
so that the staff are capable to perform their duties effectively. All the functional
managers shall have the relevant formal education.
All new staff will undergo 3 months’ probation. During the probation period, the
non-managerial staff will have to work under the mentorship of an experienced staff
assigned by the department manager.
Staff whose work could impact upon the quality of the product produced shall be given
trainings on the understanding of GMP principles and requirements as well as the
relevant SOPs and work instructions.
All personnel that access production, control and storage areas as well as handle
materials whether in-process or finished products are required to adhere to good
hygiene practices as stipulated in (SOP-02- Personnel Hygiene and Health).

2) Premises:
The manufacturing plant of Dhabe Herbals Pvt Ltd. is constructed with the
appropriate designs and measures to avoid cross contamination, materials/products
mix-up and difficult cleaning. The plant shall have adequate space to facilitate orderly
storage, logical personnel flow, material flow and equipment flow.
The production environment shall be equipped with the appropriate facilities
such as changing room, laboratory, sampling room and weighing room. Segregated
areas shall be allocated for the storage of materials or products that are rejected,
returned or under quarantine. A standard operating procedure (SOP-03-Premises) is

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maintained.
3) Equipment:
Only GMP designed equipment shall be used in the manufacturing plant. The
production equipment shall be constructed with stainless steel. They shall allow for easy
cleaning and sampling during the production process.
The production equipment is subject to installation qualification (IQ), operation
qualification (OQ) and performance qualification (PQ) before they are commissioned for
use. Every equipment shall be labelled with an identification number. An equipment log
with information such as date of use, product manufactured, batch of manufacture and
date of cleaning, shall be maintained.
Equipment and its support system shall be subject to regular service/ maintenance
by the in-house technicians or external qualified companies.

4) Raw Materials and Packaging Materials:

All raw materials and packaging materials that are purchased should meet defined
acceptance criteria relevant to the quality of finished products.

5) Production:
The manufacturing facility is equipped with a water system, which provides
purified water for use in manufacture of cosmetics. The microbiological and chemical
quality of the water shall be monitored on a regular basis. The purified water generated
shall conform to the USP standards.
Only materials with verified and traceable quality shall be used in the production.
All starting materials including the packaging materials shall be sampled, checked or
tested to confirm their compliance with the required standard and established
specifications.
Each material used in the manufacture shall be measured/weighed using
calibrated measuring instruments. Materials/products that do not meet the established
specifications shall be rejected. Re-work of reprocessing of a failed batch shall be
authorised by the Quality Control Manager.
The products manufactured shall be labelled with a batch number and expiry
date. A batch numbering log shall be maintained to facilitate the issue of correct batch
number to a new production batch.

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 6) Finished Products:
All finished products shall be approved by Quality Control Manager prior to
release. Products release, storage, shipment and returns shall be managed in a manner
so as to maintain the quality of finished products.
7) Wastes:
Waste can generated from production and quality control laboratories activities.
Waste generated is identified, handled and disposed-off to ensure it does not affect the
quality of the product. Wastes are disposed of in a timely and sanitary manner.

8) Treatment of products that is out of Specification:

Finished products, materials that are rejected and reprocessed shall be identified
and controlled to prevent their unintended use or delivery.
Rejected finished products and material is controlled as per the standard norms.
9) Deviations:
Deviations occurring in the production process should be identified, investigated
and corrective action implemented. A standard operating procedure is maintained.

10) Product Complaints and Recall:

Any product complaints and recalls should be followed-up, investigated and
corrective action implemented as required. A standard operating procedure is
maintained.

11) Change Control:

Changes that could affect the quality of product should be approved and
performed by authorized personnel on the basis of sufficient data. Change controls
related to but not limited to regulatory analytical methods and specifications, SOPs,
Product formulae, manufacturing instructions, cleaning procedures, and equipment.

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GMP SYSTEM DOCUMENTATION

General
The GMP Management System documentation includes,
a) Documented statements of a GMP safety Policy in manual and related objectives.
b) A GMP Safety Manual,
c) Documented procedures as required by the referred international standard,
d) Documents needed by Dhabe Herbals Private Limited to ensure the effective
planning, operation and control of its processes which includes GMP Safety
System procedures, Work instructions and SOP’s of products.
e) Good Manufacturing Practice system records required by the referred international
standard as well as organization’s documented GMP safety System.
Dhabe Herbals Private Limited has ensured that the established documents for GMP safety
Systems are in relevance to:
a) The size of the organization and type of activities
b) The complexity of processes and their interactions
c) The competence of personnel.

This Good Manufacturing Practice System Manual:

a) Defines the scope of the quality management system, including details of and
justification for the exclusion made.
b) Provide reference of the documented procedures established for the Good
Manufacturing Practice system.
c) Describes the interaction between the processes of the GMP Safety Management

The structure of the Good Manufacturing Practice System is

given below: Level 1 — GMP Safety Manual

FSM addresses various elements of GMP ISO 22716:2007 in the context of their
application to Dhabe Herbals Private Limited It also outlines the structure of the

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documentation used in the Good Manufacturing Practice System and makes reference to
the level 2 documents.
Level 2 — GMP Safety System Procedures

GMP System procedures and SOPs - addresses procedures followed with respect to
selected element (s) of above standards and for specific activities.
Control of Documents:
Documents of the Good Manufacturing Practice System are controlled in accordance
with documented GMP safety System procedure. It describes the structure of GMP Safety
System documentation and defines controls needed:
a) To approve documents for adequacy prior to issue.
b) To review and update as and when necessary and re-approve documents.
c) To ensure that changes and the current revision status of documents are identified.
d) To ensure that relevant versions of the applicable documents are available at points of
use.
e) To ensure that documents remain legible and readily identifiable.
f) To ensure documents of external origin are identified and their distribution controlled.
g) To prevent the unintended use of obsolete documents and to apply suitable
identification to them if they are retained for any purpose.

Control of GMP Safety System Records:

At Dhabe Herbals Private Limited, GMP safety records are established and maintained to
provide evidence of conformity to requirements and of the effective operation of the
Good Manufacturing Practice system. Quality records are kept legible, readily
identifiable and retrievable.

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MANAGEMENT RESPONSIBILITY

Management Commitment:
Management of Dhabe Herbals Private Limited is committed to the development and
implementation of the Good Manufacturing Practice System GMP ISO 22716:2007
and continually improves its effectiveness by:
a) Communicating throughout the organization - the importance of meeting
customer as well as statutory and regulatory requirement (where
applicable)
b) Ensuring that the GMP safety objectives are established,
c) Conducting management reviews.
d) Ensuring the availability of resource.

Business objectives: To enhance profits by reselling to current customers and getting new
sales through customer referrals by improving customer satisfaction. To increase
productivity by improving product functionality, decreasing prices, improving service
quality and convenience.
The top management of Dhabe Herbals Private Limited communicates the need of
addressing the customer requirements in their field of activity and the top management’s
interest in the same. In this endeavor awareness is given to employees with regard to the
importance of strict adherence to documented GMP ISO 22716:2007 Safety System
procedures, periodical audit of products and processes, monitoring and evaluation of
GMP ISO 22716:2007 safety objectives.
The management initiates necessary actions to overcome deficiency in any of the above
and this will form the means of achieving the set GMP safety Policy and objectives.

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GMP Safety Policy :
Dhabe Herbals Private Limited has established the GMP ISO 22716:2007 safety and this
policy is appropriate to the purpose of the organization and is with a vision of
organization’s future. It includes a commitment to comply with requirements and
continually improve the effectiveness of the quality management system. This policy
provides a framework for establishing and reviewing quality objectives. Management
with due delegation to key Personnel, ensure that the organization’s GMP safety Policy is
communicated and understood within the organization.
The Management review committee reviews the policy at appropriate time for its
continuing suitability, to form a basis for review, Dhabe Herbals Private Limited will:
a) Evaluate the expected level of customer satisfaction relative to competition in its
marketplace.
b) Conforms with both statutory requirement and to mutually agreed Good
Manufacturing Practice Requirement of customers.
c) Evaluate risks against achieving the organizational objectives.
d) Evaluate opportunities and need for continual improvement

Planning:
FSM Objectives:
At Dhabe Herbals Private Limited, Good Manufacturing Practice System GMP ISO
22716:2007 objectives are established and documented, which is subject to revisions
with the aim of achieving the GMP Safety Policy and to achieve continual improvement.
These objectives are measurable and are consistent with the company’s GMP Safety
Policy.
Good Manufacturing Practice System Planning:
The Good Manufacturing Practice System planning is carried out by ensuring
availability of necessary checks and controls within the processes of the quality
management system. These are documented in the QA documentation of various levels
and are subjected to periodical review for ascertaining their continued suitability and

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 effectiveness.
The integrity of Good Manufacturing Practice System is maintained whenever changes and
planned, implemented as per the clause.

Responsibility and Authority:

Responsibilities and authorities for all functions as given in the organization chart are
defined and it is communicated to the concerned people in order to facilitate effective
Good Manufacturing Practice system.
GMP ISO 22716:2007 Safety Team Leader:
Director Mrs. Archana Dhabe has been appointed as a GMP Safety Team Leader for
GMP ISO 22716:2007. Team Leader’s responsibilities and authorities are given below:
a) To Manage GMP safety Team and organize its work Ensure relevant training and
education of the GMP Safety Members.
b) Ensuring that processes needed for the Good Manufacturing Practice System are
established implemented and maintained.
c) Reporting to top management of the performance of the Good
Manufacturing Practice System and any need for improvement.

Communication
External Communication:
Dhabe Herbals Private Limited shall establish, implement and maintain arrangements for
communication with:
a) Suppliers and contractors
b) Customers or consumers in particular in relation to product information (including
instructions regarding intended use, specific storage requirements and as appropriate,
self-life), enquires, contracts or order handling including amendments, and customer
feedback including customer complaints.
c) Statutory and regulatory authorities.
Note: Designated personal shall have defined responsibility and authority to
communicate externally any information concerning GMP safety. Information

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obtained through external communication shall be included as input to system updating
and management review.
Internal Communication:
Dhabe Herbals Private Limited, good internal communication system is established that is
necessary for the effective functioning of the Good Manufacturing Practice System
processes. The internal communication systems are fax, phone, mails, display boards,
memo, oral communication, MRM and Letter correspondence.
In order to maintain the effectiveness of the Good Manufacturing Practice system, the
Dhabe Herbals Private Limited shall ensure that the GMP safety team is informed in timely
manner of changes, including but not limited to the following,

a) Products or new products.

b) Raw materials, Ingredients and services.
c) Production system and Equipments.
d) Production Premises, Location of Machinery/ Equipment, Surrounding Environment.
e) Cleaning and sanitation programmes.
f) Packing, storage and distribution systems.
g) Personal Qualification level and allocation of responsibilities and authorizations.
h) Statutory and regulatory requirements.

Emergency Preparedness:
Dhabe Herbals Private Limited has established an onsite Emergency Plan for Emergency
Preparedness & Response to identify potential for and respond to Accidents and
Emergency situations and for preventing and that can Impacts GMP Safety.

Personal Safety equipment’s are provided to the employees, working in production

sections and in other areas, as appropriate. Fire Extinguishers are provided at appropriate
locations and are tested periodically.
The emergency preparedness plan is tested once in a six months by conducting mock trials.

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Management Review:
General:
The Management reviews committee and functional heads review the Good
Manufacturing Practice System once in SIX months in the MRM (Management review
meeting) to ensure its continuing suitability, adequacy and effectiveness
The review committee evaluates the need for changes to the organization’s Good
Manufacturing Practice system, including Safety Policy and Objectives.
The Team Leader takes decision regarding the meeting date and agenda and
communicates the same to committee members through circular / displaying notice
board in advance.
Review Input:

Input to management review includes current performance and improvement

opportunities related to the following:
a) Follow up actions from previous management reviews.
b) Analysis of results of verification activities
c) Changing circumstances that can affect Good Manufacturing Practice Quality Policy.
d) Emergency situations, accidents and withdrawals.
e) Reviewing results of system-updating activities.
f) Review of Communication Activities, including Customers Feedback.
g) Internal and External Audits or Inspections.

Review Output:
The outputs from the management review include action related to:
(a) Assurance of Good Manufacturing Practice System GMP ISO 22716:2007.
(b) Improvement of the Good Manufacturing Practice System GMP ISO 22716:2007.

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 GOOD MANUFACTURING PRACTICES
QUALITY MANUAL

RESOURCE MANAGEMENT
Provision of Resource:
Management of Dhabe Herbals Private Limited ascertains by periodic review, theresource
availability and requirement to meet the situation that is influenced by factors such as,
• Changing customer needs.
• Scope for expanding business.
• Need for technology up-gradation.
• Improving work environment.
Top Management shall ensure that resources needed (identified as above) are provided.
• To implement and maintain the Good Manufacturing Practice System GMP ISO
22716:2007 and continually improve its effectiveness.
• To enhance customer satisfaction by meeting requirements.
Human Resource
General:
Management of Dhabe Herbals Private Limited ensures Personnel performing work
affecting product quality are competent on the basis of appropriate education, training,
skills and experience.

Competence, Awareness and Training:

Concerned Functional Heads ascertain the need for providing awareness and training
in identified areas.
• Provide training and take other actions to satisfy these needs.
• Evaluate the Training Effectiveness of the action taken.
• Ensures that all the persons are aware of the relevance and importance
of their activities and their contribution to achieve the defined GMP Safety
Objectives.

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 • Ensure that the requirement for effective communication is understood
by all personnel whose activities have an impact on Good Manufacturing
Practice System GMP ISO 22716:2007.
• Relevant records shall be maintained.
The training for new recruitment/existing employees is carried as per the defined
procedure for training.
Infrastructure:
Management provides necessary infrastructure needed to achieve conformity to
product requirements. Infrastructure includes, for example,
a. Buildings, Workspace and Associated utilities.
b. Process equipment, both hardware and software.
c. Supporting services such as communication etc.
Work Environment:
All functional heads jointly review with the MD during MRM to analyze and review the
present and future requirements with regard to the work environment and to manage
the work environment needed to achieve conformity to product requirements. Director
ensures that this review is conducted at least once a quarterly and that needs are
fulfilled to the possible extent considering their implications on financial status and
other business facets.
Benefits Of ISO 22716 Quality Management System Implementation For Cosmetic
Products:

 Improved legal and regulatory or contractual requirements compliance

 Products become free from external impurities and thus free from risk
 Production and service cost is reduced to lot extent.
 Process rejection and rework is reduced and subsequently eliminated at certain
stage
 Customer satisfaction is achieved by delivery of quality products every time
 Customer complaints are also reduced and eliminated
 Thorough traceability of material as well as finished product is maintained
 Lead time required to convert the raw material to finished product is reduced
 Housekeeping standard is lifted to certain level.

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 GOOD MANUFACTURING PRACTICES
QUALITY MANUAL

PLANNING AND REALIZATION OF SAFE PRODUCTS

General:
Dhabe Herbals Private Limited during the process of delivering quality and safe products to
customer ensures that the planning and manufacturing processes needed for the
product realization is carried out prior to the start of production maintaining the
consistency with the requirements of the other processes of the Management System.
This includes PRP(s) as well as operational PRP(s)
During the planning of product realization, Dhabe Herbals Private Limited determines:
1) The Objectives and requirements appropriate for the product
2) The need to establish any additional or new processes, adequacy of applicable
documents and provision of any identified resources specific to the product
3) Identification and development of measurement systems;
4) Validation of samples through Experts.
5) The required Verification, Validation, Monitoring, Inspection and test activities
specific to the product and the criteria for accepting the extent of quality and safety
of the product.
Prerequisite Programmes [PRPs]:
The QA Manager shall establish, implement and maintain PRP(s) to assist in controlling:
a) M/s. Dhabe Herbals Private Limited introducing GMP safety hazards to product through
the work environment.
b) Biological, Chemical and Physical contamination of the product(s), includingcross
contamination between herbal products.
c) GMP Safety hazard levels in the product and product processing environment.

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The PRP:
i. The size and type of operation and the nature of the products being manufactured.
ii implemented across the entire production system, either as programmes applicable in
general or as programmes applicable to particular product or operational line
approved by the GMP Safety team.
7.2.3 Dhabe Herbals Private Limited shall consider the following when establishing these
programmes.
a) Construction and layout of buildings and associated utilities,
b) Lay out Premises, including Workspace and employee facilities.
c) Supplies of air, water, energy and other utilities.
d) Supporting services, including waste and sewage disposal.
e) The suitability of equipment and its accessibility for cleaning, maintenance and
preventive maintenance.
f) Purchased materials (Raw material, ingredients, chemicals and packaging), supplies
(water, air), disposals (Waste and sewage) and handling of products (storage and
transportation)
g) Measures for the prevention of cross contamination
h) Cleaning and sanitizing
i) Pest control
j) Personal Hygiene and other aspects as appropriate
Note: Records of verification and modifications shall maintain.

Preliminary Steps to Enable Hazard Analysis:

General:
All relevant information needed to conduct the hazard analysis shall be collected,
maintained, updated and documented. Records shall be maintained.
GMP Safety Team:
The GMP safety team shall have a combination of multi-disciplinary knowledge and
experience in developing and implementing the Good Manufacturing Practice system.

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 Raw material, ingredients, product — contact materials and End product
GMP safety team needed to conduct hazard analysis
a) Biological, Chemical and Physical Characteristics.
b) Composition of formulated ingredients, including additives and processing aids.
c) Origin.
d) Method of Production.
e) Packing and delivery methods.
f) Storage Conditions and Self-life.
g) Preparation and / handling before use or processing.
h) GMP safety- related acceptance criteria or specifications of purchased
materials and ingredients appropriate to their intended uses.
i) Labeling Related GMP Safety.
Method of distribution:
Intended use:
The reasonable expected handling of end product and any unintended but
reasonably expected mishandling and misuse of end product shall be considered in
documents to the extent needed to conduct the hazard analysis.
Flow diagrams, Process steps and control measures:
Flow diagrams:
Dhabe Herbals Private Limited has made available a complete and actual description
of the operation in the form of flow diagrams (process steps), which are included
in GMP Safety Manual for the Flow Diagram, and layouts (production facilities), which
are available with the FST Leader. When applying GMP ISO 22716:2007 to a given
operation, consideration is given to steps preceding and following the specified
operation, which is evidenced in the flow diagrams and Hazard Identification &
Risk Analysis worksheet. These descriptions are drawn up and verified by the GMP
Safety team.

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 Validation Teams:
The Flow Diagrams provide a schematic overview of the operation, and describe all
the steps in sufficient detail to provide the GMP Safety Team with adequate
information for the GMP ISO 22716:2007 they take into account all relevant process
steps, such as the manufacturing of the product, including critical points like:
- Approval of materials
- Pre-preparation
- Processing
- Dispatching
All facilities which are part of the infrastructure of Dhabe Herbals Private Limited, such
as the production lines, storage areas and personnel facilities are depicted in
layout plans. In the layout plans, the following items have been indicated:
- The routing of material, personnel. This is shown in the Plant Layout.
- The areas and facilities for personnel use. This is shown in the Plant Layout.
Description of Process Steps and Control Measures:
The existing control measures, process parameters and shall described to the extent
needed to conduct the hazard analysis.
Prior to the execution of changes in the production process and layout that could
adversely affect GMP safety, these changes are reported to the GMP Safety Team in
order to evaluate potential hazards to GMP safety, and take preventive actions
accordingly. Prospective changes are reported to GMP Safety Team as per the
Documentation Control Procedure and its supporting documents.
HAZARD ANALYSIS:
General: The GMP safety team shall conduct hazard analysis to determine which hazards
need to be controlled.
Assessment:

Assessment is carried out in the organization on the basis of the GMP safety interference
sources affecting the processes. The GMP Safety interference sources considered are listed

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 out as follows :

GMP Safety Interference Sources

Machinery — Wear & Tear / Leakage Points
GMP Contact Materials — Surface Contamination of the product
Environment — external or process environment
In Process Delay — time delay
GMP Contact Surfaces — Vessels or areas where product is processed
GMP handlers — Persons handling GMP processing coming in the scope of the Organization
System — any methodology to be followed / any factor to be monitored
GMP Harborage — Potential Hazard that the GMP harbors in itself.

Based on the GMP Safety Interference Sources, each process coming under the scope of
the organization is assessed for any potential hazard posed from the GMP Safety
interference sources.

General Control Measure:

General Control Measure is identified based on the following factors.
- Specifications developed for acceptance of raw material, in process material and
finished product.
- Instructions developed for Process control.
- Procedures developed.
- Hygiene Plan.
- Sanitation Plan.
- Training Plan

Specific Control Measure:

Specific control measures are identified based on the physical / chemical parameter such as
temperature, time, pH, Visual appearance etc.
Monitoring and measurement of product

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Incoming Inspection:
Incoming Inspection is carried out as per Incoming Inspection Plan and recorded in
raw material Register and test Certificate is received from the Suppliers
In process and Final Inspection:
Products in the process stages are controlled thro effective monitoring of
manufacturing process parameters as per the relevant work instructions. The final
inspections are carried out as per the Final Inspection Plan and recorded in Analysis
report of Finished Goods. When required by customers, it is submitted to them.
Monitoring and Control of CCP:
After determining the CCP, the preventive and corrective actions are identified and
documented for each CCP. Control measures, Monitoring frequency, monitoring method,
and monitoring responsibility for each CCP are defined in concerned responsible person
monitors the CCP and make the report with his signature. The reports are reviewed and
approved Director Responsibility: Core Team.
Establishing the Operational Prerequisite Programmes [PRPs]:
The operational PRPs shall be documented and shall include the following information for
each programme.
a) GMP Safety hazard (s) to be controlled by the programme.
b) Control Measure.
c) Monitoring Procedures that demonstrate that the operational PRPs are implemented
d) Corrections and corrective action to be taken if monitoring shows that the operational
PRPs are not in control
e) Responsibilities and authorities
f) Record(s) monitoring.
Actions when monitoring results exceed critical limits
Planned corrections and corrective actions to be taken when critical limits are
exceeded as specified in the HACCP Plan. The actions shall ensure that the cause Non
conformity is identified, that the parameter(s) controlled at the CPP is brought back
under control and that recurrence is prevented.

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Updating Preliminary Information and documents specifying the PRPs.
Plan:
Dhabe Herbals Private Limited shall update the following information, if necessary
a) Product characteristics
b) Intended use
c) Flow diagrams
d) Process steps
e) Control measures

Verification Planning:
The verification activities shall conform that
a) The PRP(s) are implemented
b) Input the hazard analysis is continually updated

Traceability System:
Dhabe Herbals Private Limited ensures that Identification and traceability of the product
for its status with respect to monitoring and measurement requirements with appropriate
unique system based on the customer requirements also.
Dhabe Herbals Private Limited has implemented tags/quarantine areas to identify
different status of the product.
Dhabe Herbals Private Limited provided unique test code system for controlling all
Products/records required for traceability wherever required.
The Products are dispatched to end distribution warehouse, who shall maintain the
distribution records at their end. The products are dispatched by road, sea shipment
or by air route as per logistics requirements. Product distribution is the responsibility
of our customers/ product owners/ contract givers.
Control of Nonconformity:
Dhabe Herbals Private Limited ensures that when critical limits for CCP(s) are exceeded, or
there is loss of operational PRP(s), product which does not conform to product

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requirements is identified and controlled to prevent its unintended use or delivery. The
control and related responsibility and authority for dealing nonconforming products at
relevant stages is as per as the Procedure for Control of Nonconforming Products.
Meraki Creations, deals with nonconforming products by one or more of the following
ways:
By taking action to eliminate the detected nonconformity,
• By authorizing its use, release or acceptance under concession by a relevant
authority and if required by the customer.
• By taking action to preclude its original intended use or application.
Respective In charges maintain the records of nonconforming products and subsequent
actions taken including concessions obtained, re inspection, re verification to demonstrate
conformity to the requirements.
When nonconforming product is detected after delivery or use has started, Dhabe Herbals
Private Limited takes action appropriate to the effects, or potential effects of the
nonconformity.
Corrective Actions:
All in charges take action to eliminate the cause of nonconformity in order to prevent
recurrence. They ensure that corrective actions taken are appropriate to the effects of the
nonconformities encountered.
Procedure for corrective and preventive action FSP-10 defines requirements for
1. Reviewing nonconformities (including customer complaints) determining the
Causes of nonconformities.
2. Evaluating the need for action to ensure that nonconformities do not recur.
3 Determining and implementing action needed.
4 Records of the results of action taken.
5. Reviewing corrective action taken.
Handling of Potentially Unsafe Products:
The Dhabe Herbals Private Limited shall handle nonconforming products by taking
action(s) to prevent the nonconforming product from entering the GMP chain unless it is

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 Possible to ensure that,
a. The GMP safety hazard (s) of concern has been reduced to the defined acceptable levels.
b. The GMP safety hazard (s) of concern will be reduced to identified acceptable
levels prior to entering into the GMP chain, or
The product still meets the defined acceptable level (s) of concern despite the non-
conformity.
Evaluation for Release:
The product affected by the non-conformity shall only be released when any of the
following conditions apply:
a. Evidence other than the monitoring system demonstrates that the control measures
have been effective.
b. Evidence shows that the combined effect of the control measures for that Particular
product complies with the performance intended (identified acceptable levels).
c. The results of sampling, analysis and/or other verification activities demonstrate that
the affected lot of product complies with the identified acceptable levels for the GMP
Safety hazard (s) concerned.

Disposition of Nonconforming Products:

If the product is not acceptable for release it shall be handled by one the following
Activities.
a) Reprocessing or further processing within or outside the organization to ensure that
the GMP safety hazard is eliminated or reduced to acceptable levels.

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 GOOD MANUFACTURING PRACTICES
QUALITY MANUAL

VALIDATION,VERIFICATION AND IMPROVEMENT OF GOOD MANUFACTURING

PRACTICE SYSTEM

General:
The GMP Safety Team shall plan and implement the process needed to validate control
measures and to verify and improve the Good Manufacturing Practice System ISO
22716:2007.

Validation of Control Measure combinations:

Dhabe Herbals Private Limited shall validate that,
i. The selected control measures are capable of achieving the intended control of the
GMP safety hazard(s) for which they are designated and
ii. The control measures are effective and capable of in combination, ensuring
control of the identified GMP safety hazard(s) to obtain end products that meet the
defined acceptable levels.
If the result of the validation shows that one or both of the above elements cannot be
confirmed, the control measure and modified and re assessed.
Control of Monitoring and Measuring:
Maintenance In charge shall determine the monitoring and measurement to be
undertaken and the monitoring and measuring devices needed to provide evidence of
conformity of product to determine requirements. Concerned personnel’s shall ensure
that monitoring and measurement can be carried out and are carried out in a manner
that is consistent with the monitoring and measurement requirements.
Where necessary to ensure valid results, measuring equipment’s shall
a) Be calibrated or verified at specified intervals, or prior to use, against
measurement standards traceable to International or National
measurementstandard.

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b) Be adjusted or re-adjusted as necessary.
c) Be identified to enable the calibration status to be determined.
d) Be safeguarded from adjustments that would invalidate the measurement.
e) Be protected from damage and deterioration during handling, maintenance and
storage.
In addition, they shall record the validity of the previous measuring results when the
equipment is found not to conform to requirements and take appropriate action on the
equipment not to affect the product. The records of calibration and verification shall be
maintained.
Good Manufacturing Practice System Verification:
Internal Audit:
Dhabe Herbals Private Limited, plans and conduct internal audits every 3 months
intervals to determine whether the FSMS
• Conforms to the planned arrangements, to the requirements of the standards
and FSMS requirements established by Dhabe Herbals Private Limited effectively
implemented and maintained.
Management Representative plans for the audits considering the status and the
importance of the processes and areas to be audited, as well as the previous audit
results.
The audit criteria, scope, frequency and methods shall be defined. Selection of
auditors and conduct of audits shall ensure objectivity and impartiality of the audit
process.
Auditors shall not audit their own work.
The responsibility and requirements for planning, conducting audits, reporting
results and maintaining records shall be as per the procedure for Internal Audit.
Evaluation of individual verification results:
The GMP safety team systematically evaluates the individual results of planned verification.
a. Existing procedure and communication channels.
b. The conclusion of hazard analysis the established operational PRP(s) and the
HACCP plan.

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 c. The PRP(s) and the effectiveness of human resource management and of
training activities.

Analysis of results of Verification activities:

The GMP safety team shall analyses the results of verification activities, including the
results of internal audit and External audits. The analysis shall be carried out in order
to conform that the overall performance of the system meets the planned
arrangements and the Good Manufacturing Practice system requirements established by
the Meraki Creations, to identify the need for updating or improving the Good
Manufacturing Practice system, to identify the trends indicate a higher incidence of
potentially unsafe products, to establish information for planning the internal audit
programme concerning in the status and importance of areas to audited and to provide
evidence that any corrections and corrective actions that have been taken are effective.

Continual Improvement:
Dhabe Herbals Private Limited is committed to continually improve the effectiveness of the
Good Manufacturing Practice System through the use of Good Manufacturing Practice
Policy, evaluation of individual verification results, analysis of results of verification
activities , verification of control measure combinations, corrective actions, Good
Manufacturing Practice System updating , audit results, analysis of data, corrective and
preventive action and management review.

Safety Management System Updating:

Management shall ensure that the Good Manufacturing Practice system is continually
updated. In order to achieve this, the GMP safety team shall evaluate the Good
Manufacturing Practice system planned interval.

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