GOOD MANUFACTURING PRACTICES (GMP) AND QUALITY : GOOD MANUFACTURING PRACTICES (GMP) AND QUALITY L RAMARAO
MANAGEMENT OF QUALITY : MANAGEMENT OF QUALITY What is quality?
Quality is meeting the intended use requirement – A mere mundane definition
Quality is satisfying a customer – a better response
Satisfying a customer may not be adequate
Delighting a customer, a more appropriate definition
MANAGEMENT OF QUALITY : MANAGEMENT OF QUALITY Such definitions do not hold water when it comes to Pharmaceuticals
Meeting GMP, or rather more precisely, cGMP means quality standard have been met.
Quality must be designed and built into the product;
Quality cannot be tested into the product
Each step in a manufacturing process must be controlled, to maximize the probability that the finished product meets all its quality and design specifications.
MANAGEMENT OF QUALITY : MANAGEMENT OF QUALITY What is GMP?
GMP is a part of Quality assurance that ensures that each unit of product meets the end use requirements of Identity, Efficacy, Quality, Purity and Safety in each unit of product till the presumed shelf life of product
Good Manufacturing Practice (GMP) is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation (MA) or product specification. GMP is concerned with both production and quality control. (UK MHRA)
MANAGEMENT OF QUALITY : MANAGEMENT OF QUALITY What is GMP?
GMP is that part of quality assurance which ensure that products are produced consistently and controlled to meet their end use requirements
GMP is defined as a means of assuring that the product is free from contamination and cross contamination
GMP is aimed primarily at reducing the risks inherent in any pharmaceutical production
GMP involves both Quality assurance and Quality control
MANAGEMENT OF QUALITY : MANAGEMENT OF QUALITY What is GMP?
Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use.
Quality control covers all measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that raw materials, intermediates, packaging materials and finished pharmaceutical products conform with established specifications for identity, strength, purity and other characteristics
MANAGEMENT OF QUALITY : MANAGEMENT OF QUALITY Origin of GMP
It is truism that it takes a disaster to wake up people especially regulators to review the accepted way of things.
Some of the disasters which woke up regulatory authorities Internationally and Nationally
Elixir of Sulphanilamide – contained an anti freeze – which killed 105 children in USA in 1937
Contaminated IV fluids killed 7 people in 1972
Anti fever medication in Haiti thought to contain Glycerine (never tested) killed 87 children
Thalidomide taken by pregnant mothers leads to birth of children without ears, fully formed fingers and so on in UK
In 1983, Tylenol capsules were replaced with Potassium Cyanide capsules by a Psychic in a super bazaar killing several people
Nearer home, an anti- bacterial tablet containing a diabetic drug killed old people in Karnataka in 1996
Anthelmentic syrup containing ethylene glycol, instead of Propylene Glycol kills several children in Tamil Nadu (then called as Madras )
MANAGEMENT OF QUALITY : MANAGEMENT OF QUALITY Origin of GMP
The first draft of GMP was drafted by a group of consultants in 1967 for WHO at the request of World Health Assembly
Revised text was discussed in 1968, amended and included in 2nd edition of International Pharmacopoeia
In 1969, a certification process was started by WHO
Revised versions of certification as well as GMP requirements was accepted by WHO in 1975
Revisions have taken place from time to time
MANAGEMENT OF QUALITY : MANAGEMENT OF QUALITY Types of cGMP systems
Schedule M of Drugs and Cosmetics Act – as amended
WHO standards of cGMP
Therapeutic Goods Administration – Australia
US Federal drugs Administration – USFDA
Medicines and Healthcare Products Regulatory agency - UK MHRA
European Directorate for quality of Medicines - EDQM
MANAGEMENT OF QUALITY : MANAGEMENT OF QUALITY Types of cGMP systems
Is there any difference in these systems?
Yes – to a large extent Schedule M and WHO standards tend to be interpreted by regulatory personnel in a more lenient manner based on Geographical location of manufacturing units
No - Health of personnel are involved- all regulations have enough teeth to ensure pharmaceutical products of right quality enter the market
MANAGEMENT OF QUALITY : MANAGEMENT OF QUALITY QUALITY MANAGEMENT SYSTEM FOR MANUFACTURING TO ENSURE cGMP COMPLIANCE
Quality system
Quality is everybody’s responsibility
Because it is everybody’s responsibility, it is in danger of becoming nobody’s responsibility.
So, it is the responsibility of Top management to send a message loud and clear that there can be NO COMPROMISE on Matters related to Quality
Hence the need for a quality management system
MANAGEMENT OF QUALITY : MANAGEMENT OF QUALITY QUALITY MANAGEMENT SYSTEM FOR MANUFACTURING TO ENSURE cGMP COMPLIANCE
Therefore quality system should have:
Organizational structure -In form of organizational charts
Responsibilities - In form of job responsibilities
Procedures - In form of Standard operating procedures
Processes - In form of master formula and batch production records
Activities to ensure that the product will meet its intended specifications - By providing
Resources
Suitable facility, personnel, training, metrology etc.,
Documentation
Sampling plans, standard test methods, product specifications etc.,
Operational reviews
Batch release for sale, recalibration programs, GMP audits, trend analysis etc.,
MANAGEMENT OF QUALITY : MANAGEMENT OF QUALITY QUALITY MANAGEMENT SYSTEM
In order to achieve the above objectives of cGMP, there should be quality unit(s), which fulfill both QA and QC responsibilities.
Steps to be taken to maintain quality system:
All activities should be recorded at the time they are performed.
Any deviation from established procedures should be documented and explained.
No material should be released or used before evaluation by the quality unit (s).
Procedure should be available for informing responsible management about deviations and GMP non-compliances.
MANAGEMENT OF QUALITY : MANAGEMENT OF QUALITY QUALITY MANAGEMENT SYSTEM
Basic Quality unit functions - QC
Releasing or rejecting raw, intermediate, final product, packaging materials and labeling components
Carry out stability studies
MANAGEMENT OF QUALITY : MANAGEMENT OF QUALITY QUALITY MANAGEMENT SYSTEM
Basic Quality unit functions – QA
Ensure critical non-compliances are reviewed and resolved.
Approve specifications and master production records
Ensure internal audits are performed
Ensure all validations are performed
Approve changes that potentially affect product quality
Quality related complaints are investigated and resolved
Ensure all measuring equipment is calibrated.
Product quality reviews are made
Must approve all quality related documents. Eg., SOPs, review of process validation, OOS, establishment of specifications etc.,
The End : The End Thank you