Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use. (GMP) comes in Schedule M in D & C Act 1940 and Rules 1945. GMPs are the requirements that the drug and methods/control /facilities used in their manufacturing, processing and packaging conforms to practice that will assure the safety and efficacy of the product.

1. Quality Control & Standardization Of Herbals
GMP Requirements & D&C Act Provision
By
Kaushal Kumar

2. TABLE OF CONTENTS
01 02 03 04
Introduction Part of GMP Quality Assurance Quality Audit

3. Good Manufacturing Practices (GMP) is that part of quality
assurance, which ensures that products are regularly produced
and controlled according to the quality standards suitable for their
use.
(GMP) comes in Schedule M in D & C Act 1940 and Rules 1945.
GMPs are the requirements that the drug and methods/control
/facilities used in their manufacturing, processing and packaging
conforms to practice that will assure the safety and efficacy of the
product.
GMPs include a set of practices that ensure quality at every level
of operation in industry.
Introduction

4. → It used in the manufacture of drugs are authentic, of prescribed quality.
→ Free from contamination.
→ Manufacturing process has been prescribed to maintain the standards.
→ Adequate quality control measures are adopted.
→ Manufactured drug which is released for sale is of acceptable quality.
Objective Of GMP

5. Consideration
Raw Materials
Quality
Assurance
Record Keeping
of Substance
Standard For
Cleanliness &
Safety
Qualification of
Personnel
In House
Testing
Production &
Process Control
Warehousing &
Distribution

6. Different Part of GMP
 General provisions
 Organization and personnel
 Building and Facilities
 Equipment's
 Control of components, drug product containers and closures
 Production and process control
 Production and process control
 Holding and Distribution
 Laboratory Control
 Records and Reports
 Returned and Salvaged drug product

7. General Provision
The regulation in this part contains the minimum cGMP for preparation of drug products for
administration to human beings or animals.
Organization and personnel
The establishment and maintenance of a satisfactory system of quality assurance and the
correct manufacture of quality products relies upon people.
For this reason, there must be sufficient qualified personnel with the necessary qualifications
and practical experience to carry out all the tasks which are the responsibility of the
manufacturer.
General Requiremnet

8. Building and Facilities
Design &
Construction
Washing
& Toilet
Facilities
Maintenance
Premises
Ventilation
& Air
filtration
Plumbing
Sanitation

9. Equipments
Equipment's
Design Size
& Location
Construction
Cleansing &
Maintenance
Mechanic &
Electronic

10. Control of components, drug product containers and closures
There should be written procedures describing in details of receipt, identification, storage,
handling, sampling, testing and approval or rejection of components and drug product
containers and closures.
Production and process control
There should be written procedure for production and process control designed to assure
that the drug products have the identity, strength, quality and purity that they are
represented to possess.
To assure the batch uniformity and integrity of drug products. written procedures have to be
established to monitor the output and to validate the performance of the manufacturing
process responsible for causing variability.
Part of GMP

11. Packaging and labeling control
Labeling and packaging materials should be examined or tested upon receipt and before
use in packaging or labeling of drug products.
Packaged and labelled products have to be examined after finishing the operations to
assure that containers and packages in the lot have the correct label.
Holding and Distribution
 Warehouse procedure include: - Storage of drug products under appropriate conditions of
temperature, humidity and light so that, the identity, purity of drug products are not affected.
 Distribution procedure include: - Oldest approved stock of drug product is distributed first.
Distribution of each lot of drug product can be readily determined to facilitate its recall if
necessary.
Part of GMP

12. Laboratory Control
Laboratory control should include, appropriate specifications, standards, sampling plans and
test procedures designed to assure that components, drug product containers, closures, in-
process materials conform to appropriate standards of identity, strength, quality and purity.
Records and Reports
Production, quality control and distribution records are required to be maintained and should
be retained for at least 1 year after the expiration of the batch.
Part of GMP

13. Quality Assurance (QA) testing is an activity to ensure that an organization is providing the
best possible product to customers. QA focuses on improving the processes to deliver
quality products to the customer.
Quality assurance has a defined cycle called PDCA.
 Plan: Organization should plan and establish the process related objectives and determine
the processes that are required to deliver a high quality end product.
 Do: Development and testing of processes and also “do” changes in the processes.
 Check: Monitoring of processes, modify the processes and check whether it meets the
predetermined objectives.
 Act: Implement actions that are necessary to achieve improvements in the processes.
Quality Assurance

14. Quality Assurance production steps
 General requirements: Handling of materials and products such as, receipt, sampling,
storage should be done in accordance with a written procedure.
 Prevention of cross-contamination and bacterial contamination in
production: Protective clothes should be worn, provided with appropriate air lock and
pressure differentials.
 Processing operations: Intermediate and bulk products, In-process control and
environmental control.
 Packaging operation: Filling, sealing, printing, embossing should be distinct and
resistant to fading or erasing.
Quality Assurance

15. Quality audit is the process of regular examination of a quality system carried out by an
internal or external quality auditor or an audit team.
This helps to determine if the pharmaceutical industry complies with the defined quality
system processes and can involve procedural or results-based assessment criteria.
Quality Audit
• Process
Quality Audit
• Product
Quality Audit
• System
Quality Audit

16. THANKS!
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