GMP AND cGMP CONSIDERATIONS Department of pharmaceutics

GMP SEAL

What is GMP ? GMP is a part of Quality assurance which ensures that the products are consistently manufactured and controlled to the Quality standards appropriate to their intended use "GMP" - A set of principles and procedures which, when followed by manufacturers for therapeutic goods, helps ensure that the products manufactured will have the required quality

GMP also……… Good Manufacturing Practice Good Management Practice Get More Profit Give more Production

Good Manufacturing Practices A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

Some of the main risks are unexpected contamination of products, causing damage to health or even death. incorrect labels on containers, which could mean that patients receive the wrong medicine. insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.

Why GMP is important A poor quality medicine may contain toxic substances that have been unintentionally added. A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect

GMP Covers… ALL aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.

QA, GMP & QC inter-relationship Department of Pharmaceutics

QA It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use

GMP Is a part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use

QC Is a part of GMP concerned with sampling, specification & testing, documentation & release procedures which ensure that the necessary & relevant tests are performed & the product is released for use only after ascertaining it’s quality

Ten Principles of GMP Design and construct the facilities and equipments properly Follow written procedures and Instructions Document work Validate work Monitor facilities and equipment Write step by step operating procedures and work on instructions Design ,develop and demonstrate job competence Protect against contamination Control components and product related processes Conduct planned and periodic audits

List of important documents in GMP Policies SOP Specifications MFR (Master Formula Record) BMR (Batch Manufacturing Records) Manuals Master plans/ files Validation protocols Forms and Formats Records

10 attributes of a good document Accurate Clear Complete Consistent Indelible Legible Timely Direct Authentic Authorized

Certifying agencies ICH. www.ich.org WHO. www.who.int US FDA. www.fda.gov EU/EMEA. www.emea.europa.eu

How do GMPs of different countries compare? At a high level, GMPs of various nations are very similar; most require things like: Equipment and facilities being properly designed, maintained, and cleaned Standard Operating Procedures (SOPs) be written and approved An independent Quality unit (like Quality Control and/or Quality Assurance) Well trained personnel and management

cGMP For Finished Pharmaceuticals General Provision Organization & Personnel Building & Facilities Equipment Control of Components & Drug Product Containers & Closures Production & Process Control Packaging & Labeling Control Handling & Distribution Laboratory Control Records & Reports Returned & Salvaged Drugs

General Provision Scope Definitions

Organization & Personnel Responsibilities of quality control unit. Personnel qualifications. Personnel responsibilities.

Building & Facilities Design and construction features. Lighting. Ventilation, air filtration, air heating and cooling. Plumbing. Sewage and refuse. Washing and toilet facilities. Sanitation. Maintenance.

Pharmacy Building

Equipment Equipment design, size, and location. Equipment construction. Equipment cleaning and maintenance. Automatic, mechanical, and electronic equipment. Filters.

Tablet Punching Machine Pulverizer

End Runner Capsule Filling Machine

Control of Components & Drug Product Containers & Closures General requirements. Receipt & storage of untested components, drug product containers, and closures. Testing and approval or rejection of components, drug product containers, and closures. Use of approved components, drug product containers, and closures. Retesting of approved components, drug product containers, and closures. Rejected components, drug product containers, and closures. Drug product containers and closures.

Production & Process Control Written procedures; deviations. Charge-in of components. Calculation of yield. Equipment identification. Sampling and testing of in-process materials and drug products. Time limitations on production. Control of microbiological contamination. Reprocessing.

Packaging & Labeling Control Materials examination and usage criteria. Labeling issuance. Packaging and labeling operations. Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. Drug product inspection. Expiration dating.

Storage & Distribution Warehousing procedures. Distribution procedures.

Laboratory Control General requirements. Testing and release for distribution. Stability testing. Special testing requirements. Reserve samples. Laboratory animals. Penicillin contamination.

Records & Reports Production record review. General requirements. Equipment cleaning and use log. Component, drug product container, closure, and labeling records. Master production and control records. Batch production and control records. Production record review. Laboratory records. Distribution records. Complaint files.

Returned & Salvaged Drug Products Returned drug products. Drug product salvaging.

References Blackwell, John. 1906: Rumble Over ‘The Jungle’. 31 Aug. 2008. http://www.capitalcentury.com/1906.html FDA Food and Drug Administration. GMP Combination Handbooks. 31 Aug. 2008. http://images.google.com The Center for Professional Advancement. Good Manufacturing Practice. 2008. 1 Sep. 2008. http://www.cfpa.com/gmp-training The New York Times. 1906 Meat Processing Plant. 26 Jan. 2005. 31 Aug. 2008. http://www.nytimes.com/imagepages/2005/01/26/national/26meat.ready.html Torrent Pharmaceuticals Ltd. Pharmaceutical GMP: past, present, and future–a review. 2008. 31. Aug. 2008. http://www.atypon-link.com/GVR/doi/abs/10.1691/ph.2008.7319?cookieSet=1&journalCode=phmz

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