GMP stands for good manufacturing practice and it is a set of guidelines introduced by the US-FDA(Food and Drug Administration).In this article, we will read about
- What is GMP?
- Chapters of GMP.
- Difference between GMP and cGMP.
- 21 CFR.
Definition of GMP
GMP is a combination of procedures and documentation that confirms that all products are always manufactured according to quality standards.
- As the name indicates GMP consists of all the good practices which are required for the manufacturing, packaging, testing and distribution of pharmaceutical products.
- GMP are the guidelines which ensure that high-quality standards are maintained in all batches of the product and the product is safe for use, no risks are associated with the use of this product and it is free from contamination.
- GMP defines guidelines for all the departments of pharmaceutical industries.
- GMP defines the working culture of pharmaceutical industries.
- It defines the role and requirement of all personnel working in pharmaceutical industries.
- GMP deals with all the departments in a broader aspect.
It is a common question that why pharmaceutical industries require GMP certification?
The answer to this question is that GMP gives assurance to the consumers that products manufactured here are of high quality and fit for use without any harmful effect.
We will understand the need of GMP from a simple example given below.
Suppose we want to eat burgers and we have two options.
Option No 1.
The first option is the VIP burger shop by a multinational brand.
Option No 2.
Option no 2 is a local burger cart on the corner of the road.
We will prefer to eat a burger from option no 1 because we see that the building and environment inside the shop is neat and clean, the air conditioning system and security cameras are installed, and the staff is well dressed and trained.
It is all because this shop follows some standard guidelines and always works according to the provided guidelines.
In case of option no 2, the cart on the corner of the road has no system of cleaning, the proper sitting arrangement is not available and the staff is not educated or trained and they do not know about any working guidelines.
So good quality food will not be available there because they have no standards.
- In the same way, GMP defines standards and guidelines for Pharmaceutical industries for every aspect starting from building layout to manufacturing practices.
- In simple words, GMP enforces the pharmaceutical industries to build quality in each product to maintain quality standards to gain customer trust.
Chapters of GMP
GMP has the following 7 chapters
- Pharmaceutical Quality system
- Premise and Equipment
- Quality Control
- Complaints and product recall
Pharmaceutical Quality system
It has many guidelines some are as follow,
- Products are manufactured according to GMP.
- Production and control operations are defined.
- Managerial responsibilities are defined.
- Procedure for self-inspection is available.
- GMP is implemented by the people working in pharmaceutical industries so they should be properly trained.
- A training calendar should be available for all the staff.
- Training providers should also be qualified.
Premice & Equipment
- The building should be situated in an area suitable for manufacturing activities and should not affect the surroundings.
- Guidelines are given for building layout, size and design for all areas like for production area, Quality Control area, storage area etc.
- Proper Environmental Conditions like temperature and humidity should be maintained.
- Systems and Procedures should be available to prevent cross-contamination.
Guidelines for Equipment size, designing, handling and Preventive maintenance are defined.
- Guidelines for good documentation practice are defined.
- All processes should be written.
- Manufacturing record is stored properly.
Guidelines for production activities are defined.
Guidelines for the quality control department are defined.
Complaints and Recalls.
Procedure and guidelines for handling of complaints and product recall are defined.
What is cGMP?
cGMP(Current Good Manufacturing Practice)
- cGMP is currently Good Manufacturing Practice.
- c in the cGMP stands for current and cGMP mean current good manufacturing practices.
- c is always written in small letters and represents a continuous improvement.
- Current means use of most latest or recent techniques.
Difference Between GMP and cGMP(GMP vs cGMP).
cGMP is the current version of GMP or use of currently available or recent techniques is called cGMP.
With time, cGMP becomes GMP and new arrival practices become cGMP.
- GMP defines the guidelines to get the required results.
- cGMP defines the use of the currently available or recent techniques to get the required results.
- The basic concept of GMP remains constant like Documentation is the requirement of GMP and we have to prepare and maintain a proper document record.
- cGMP is continuously changing with the development of new techniques like documentation changes from papers to electronic systems.
We can further understand the difference between GMP and cGMP on the following basis.
Based on Technology
The example to understand the difference between GMP and cGMP is that in old-time the physical balance was used to weigh the ingredients.
It is the GMP requirement to weigh all ingredients during dispensing, manufacturing and other critical operations in pharmaceutical industries.
At that time the use of physical weighing balance was cGMP meaning the latest method available to weigh the ingredients.
When electronic analytical balances were introduced to weigh the ingredients it became cGMP and the use of physical balance became GMP.
With time use of physical balance was stopped and the use of electronic analytical balances became GMP.
Later on, it became the latest practice to attach a printer with the analytical balance to get results of all to weigh in print form so it became cGMP and use of simple analytical balance became GMP.
In many pharmaceutical industries, conventional old compression machines are used to compress the tablets.
Some industries use recently available auto rejection and auto adjustment compression machines with dust control systems to prevent cross-contamination.
These machines full fill the requirements of cGMP.
2.0 Product Quality
In pharmaceutical industries, every unit of the batch can not be tested before its release to the market.
Quality control analysts use only a small portion of the sample from the whole batch and test it to release the whole batch.
Quality should be built in the product by the latest techniques and the advance level of checking and testing should be conducted.
Some pharmaceutical industries use conventional techniques for product analysis but many pharmaceutical industries use recent or advanced techniques to find by products or impurities present in the product along with API. It ensures a more stable product quality.
3.0 Record keeping
It is a regulatory requirement to note and record every activity during the manufacturing process.
It can be written in manual forms to meet the GMP requirements.
cGMP uses paperless working using electronic signatures and electronic BMRs.
- Cost also makes the difference between GMP and cGMP.
- As GMP is conventional and cGMP is an advanced type of GMP so the cost for advanced techniques and equipment is more than GMP.
- GMP is adopted by a large number of pharmaceutical industries.
- cGMP is adopted by a few pharmaceutical companies.
Code oF Federal Regulations (21CFR)
CFR is Code of Federal Regulations and it is a combination of many guidelines published by the US federal department and is published in the official federal register.
Structure Of CFR
CFR consists of 50 titles.
Each Title deals with different fields like
Title 1 =General provisions
- Title 4 =Account
- Title 10= Energy
- Title 12 =Banks and banking
- Title 21 =Food and drug(For Pharmaceuticals)
and so on up to 50 titles.
- Each title is further divided into chapters and each chapter is divided into subchapters and parts.
- The title represents complete sector or field meaning each title includes specific guidelines for specific fields.
- Chapters represent inspecting body like FDA etc
- Chapters are further divided into subchapters and parts.
What is 21 CFR?
- The 21st title of CFR deals with food and drugs so in pharma it is commonly known as 21 CFR.
- 21 CFR is cGMP guidelines for all the departments and sections of pharmaceutical industries.
- Any pharmaceutical industry or plant which wants FDA approval or wants to export drugs to the USA must follow guidelines of 21 CFR.
Food and drugs
- Title 21 of CFR is divided into the following 3 chapters
Food and Drug Administration.
Drug Enforcement Administration.
Office of National Drug Control Policy.
Chapter 2 is divided into 12 subchapters from A to subchapter L.
- Subchapters are divided into parts.
- Three important parts of Subchapter C are as follow,
- Part 201
- Part 210
- Part 211
Part 201 deals with labelling guidelines.
- Part 210 deals with guidelines for manufacturing unit activities like raw material dispensing, manufacturing, packaging till finish products.
- Part 211 deals with guidelines for the finished products.
- It gives guidelines for testing of finished products.
- Cleanroom classification in pharmaceutical industries.
- HVAC or Heating Ventilation & Air Conditioning System.
- Loop Circulation system for purified water.
- How to get protection from Coronavirus in pharma.
- Potency calculation of Active pharmaceutical Ingredient.
- Wet granulation & Dry Granulation in pharmaceutical industries.
- Advancements Granulation Techniques.
- Endpoint determination or wet granulation.