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GMP. GOOD MANUFACTURING PRACTICE. DEFINITION ‘ GMP is that part of quality assurance which ensures that products are Consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. Quality.
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GMP GOOD MANUFACTURING PRACTICE
DEFINITION ‘GMP is that part of quality assurance which ensures that products are Consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization
Quality • Conformance to requirements • Fitness for purpose • Absence of defects
Quality of Pharmaceutical products • Performance • Features • Durability • Service • Reliability • Aesthetics • Conformance • Perceived quality
1. Performance A pharmaceutical product must always be • Safe • Pure • Effective
3. Durability • It indicates the stability of the product The defined qualities of the product should show throughout its shelf life
4. Aesthetics • Right container and closure system
5. Reliability Trust of the customer, regulatory agencies and medical professionals
6. Service • Means product availability and complaint resolution
7. Conformance The product should meet the agreed specifications.
8. Perceived quality Means attending to even unexpressed expectations.
SISPQ values of GMP • Safety • Identity • Strength • Purity • Quality
“GMP” for the first time • USFDA used the term “GMP” for the first time in 1962. • This was coined by the Ke Fauver & Harris committee • Insisted that medicines to be manufactured in a consistent manner
GMP became cGMP in 1976 • The first guideline for medical products came into existence
India • We follow Drugs and Cosmetics Act,1940 • Drugs and Cosmetics rules • Revised schedule M for GMP
GMP • Is used internationally to describe a set of principles and procedures, which,when followed by manufacturers help in ensuring that the products manufactured will have the required quality. • GMP cannot be tested into a batch of product • It must be built into each batch of product during all stages of the manufacturing process.
In other words • GMP is a set of current scientifically sound methods,practices or principles that are implemented and documented during product development and production to ensure consistent manufacture of safe,pure and potent products
Schedule M • Location • Building • Water system • Waste disposal • Warehousing area • Production area • Ancillary areas
Schedule M contd… • Personnel • Health,clothing and sanitation of workers • Manufacturing operations and controls • Precautions against mix ups and cross-contamination • Sanitation in manufacturing premises • Raw materials
Schedule M contd… • Equipment • Documentation and records • Labels and other printed materials • Quality Assurance • Self inspection and quality audit • Quality control system • Master formula records
Batch packing records • Standard Operating Procedure and records • Sampling • Testing • Records of analysis • Reference samples • Reprocessing and recoveries • Distribution records
Validation • A process is validated • Equipment is qualified • Validation is the confirmation of the process • It is not an additional testing • It is different from calibration
Process is validated It is the confirmation of the process Validation proves the quality of a process but does not improve the quality of a process Accuracy of working instrument is calibrated Calibration is done against another instrument which is more accurate Traceable to national standards whichis close to accuracy Validation & Calibration
Equipments 1. Material of construction (MOC) MOC should be :- • Non reactive • Non additive • Non absorptive
2.Operation • The equipment should be operated as per the required specification
Cleaning • The equipment could either be dismantled taken out of the shop floor(COP) or • Cleaning in Place (CIP)
Building The facility should be easy to • Operate • Clean • Maintain
WastesPaper to be incineratedPlastic/Rubber to be cut into unusableparts as scrapGlass to be crushedFood is the most critical waste should be kept unexposed and disposed through external agencySeparate area to be designated as ‘waste hold area’
Premises Schedule M insist that a medical product Factory should not be located near slum, public toilets,or schools
Contamination 2 types of contaminants Particles 1.viable 2.nonviable-a) active b) inert Particles 1.visible 2.nonvisible
Control of quality of air HVAC- Heated ventilating air change AHU- Air handling unit HEPA filter
Don’ts inside the clean room • Never eat or drink inside the clean room • Never chew pan or take medicines inside the clean room • Never take jewellery ,bindis,personal belongings inside the clean room • Never block the riser( air exhaust)
Do s inside the clean room • Always follow SOPs • Avoid generation of dust and if generated arrest it • Movement inside the clean room should be in such a way that the air flow is not disrupted
Personnel People should have The right kind of education Requisite experience Training Medical fitness
Precautions against mix ups Material under process shall be conspicuously labeled to demonstrate their status Packaging lines shall be independent and adequately segregated Printing machines shall be clean and free from any products Line clearence shall be performed according to appropriate checklist
Documentation and record 7 qualities of a good document • permanent in an indelible ink • legibility is of prime importance • Clear • Consistent • Timely and truthful
Inside the clean room • Operator should check the integrity of dress • Movements should be steady, slow • Approach to others from behind and not from the front • No contaminating items inside the clean room • Cleaning should not be vigorous • While material handling avoid turbulence
