cGMP/current Good Manufacturing Procedures is the system to ensure the integrity and quality of product which is established by set of guidelines.
Guidelines are standards for manufacturing the medical products that is established by Government bodies or by Authorized committees called regulatory agency. Some of the guidelines as follow
ICH (International conference on Harmonization for technical) this is an committee organized between USA, Japan and Europe to have a common market platform and ICH is accepted and adopted worldwide as their guidelines.
USFDA (United states Federal Drug Authority) an government agent of United states that controls the manufactures of medical products which is intended to sell the medicines in United states.
EMA (European Medicine Agency) & EDQM (European Directorate for the Quality of Medicines) is applicable for European Union
MHRA (Medicines and Healthcare products Regulatory Agency) is applicable for United Kingdom.
PICS (Pharmaceuticals inspection Co-operation Scheme) this is a general agency which this guidelines is adopted by some countries like Australia (TGA), Sweden etc.
WHO (World Health Organization) is an independent agency which is having set of guidelines which only WHO is using for inspection and approval of manufacturer for procurement which WHO distribute the products in some countries like Africa etc.
Why those need to be followed?
If a manufacturer of medicine needs to export the medicine the manufacture has to adopt the country’s GMP guidelines to their GMP system.
Say Eg:
If “X” is a manufacturer and want to export the medicines to country “Y” the manufacturer “X” has to adopt the guideline of the that particular county “Y” to their organization GMP system. For more see the topic
What is Regulatory?
Regulatory Agencies are government bodies which will ensure the quality and integrity of the medicines which is going for consumption to the country peoples, for more information see what is Regulatory?
“In practical, GMP is combination of standard industrial practices and adopting the guidelines to the industry with logical approach”
What is Guidelines?Guidelines are standards for manufacturing the medical products that is established by Government bodies or by Authorized committees called regulatory agency. Some of the guidelines as follow
ICH (International conference on Harmonization for technical) this is an committee organized between USA, Japan and Europe to have a common market platform and ICH is accepted and adopted worldwide as their guidelines.
USFDA (United states Federal Drug Authority) an government agent of United states that controls the manufactures of medical products which is intended to sell the medicines in United states.
EMA (European Medicine Agency) & EDQM (European Directorate for the Quality of Medicines) is applicable for European Union
MHRA (Medicines and Healthcare products Regulatory Agency) is applicable for United Kingdom.
PICS (Pharmaceuticals inspection Co-operation Scheme) this is a general agency which this guidelines is adopted by some countries like Australia (TGA), Sweden etc.
WHO (World Health Organization) is an independent agency which is having set of guidelines which only WHO is using for inspection and approval of manufacturer for procurement which WHO distribute the products in some countries like Africa etc.
Why those need to be followed?
If a manufacturer of medicine needs to export the medicine the manufacture has to adopt the country’s GMP guidelines to their GMP system.
Say Eg:
If “X” is a manufacturer and want to export the medicines to country “Y” the manufacturer “X” has to adopt the guideline of the that particular county “Y” to their organization GMP system. For more see the topic
What is Regulatory?
Elements of GMP | GLP
GMP is constructed based on the following elements. These elements are applicable in all the sections. Manufacturer setting up a GMP has to consider the following by default.
a) Integrity
b) Traceability
c) Identity
d) Contamination or cross contamination
e) Accuracy
f) Prevention
g) Validation
h) Qualification
Tools of GMP
GMP is ensured by the tools
1. Quality assurance
2. Building and maintenance
3. Production process
4. Material Management
5. Laboratory management
6. Packing & Labelling
GMP from regulatory to Industry an overview
Regulatory bodies >>> Guidelines > > > cGMP (current Good Manufacturing Practices) >>> (QMS) Quality Management Systems >>> SOPs (Standard Operating Procedure) >>> Compliance
GMP Guidelines
These are the general GMP guidelines which is applicable. However there are other guidelines from the particular agency which covers the particular topic.
Before getting in to your guidelines ensure which is your applicable section. Go through the guideline Objective and Scope thoroughly before implementing. (Eg: API manufacturing, finished dosage forms, Biologicals manufacturing)
GMP related Guidelines Download and reference:
USFDA: 21CFR Part 11 Current Good Manufacturing Practice for Finished Pharmaceuticals
PICS cGMP Guidelines: For Active Pharma Ingredients
WHO Guideline: WHO GMP Guidelines for Active Pharma Ingredients (API)
WHO GMP Guidelines for Finished products
WHO GMP guidelines for Biologicals
WHO GMP guidelines for Herbals
WHO GMP Guidelines for Quality Control Labs
WHO GMP Guidelines for Excipients manufacturing
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