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Current Good Manufacturing Practices (CGMP) in Pharmaceutical Industry

Good Manufacturing Practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacturing and sale of pharmaceutical products. These guidelines provide minimum requirements that a manufacturer must meet, to assure that their products are consistently high in quality, from batch to batch, for their intended use. The GMP is also applicable to food and beverages, cosmetics, dietary supplements and medical devices.

The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user , which include ensuring that the end product is free from contamination, that it is consistent in its manufacture and has been well documented. The personnel are well trained, and the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system.

Current Good Manufacturing Practices (CGMP) in which "C" stands for "Current," requires companies to use technologies and systems that are up-to-date in order to comply with the regulations. It provides for the systems that assure proper design, monitoring and control of manufacturing processes along with facilities hence ensuring the identity, strength, quality and purity of drug products being manufactured.

The Manufacturers of Medicines have adequate control on manufacturing operations, which involves establishing of strong quality management systems, procuring quality raw materials, operating procedures, detecting and investigating deviation in quality of product, reliable testing laboratories. If adequately put into practice, CGMP prevents incidences of product mix-ups, contamination , deviations, failures, and errors which in turn assures that drug products meet the required quality standards.

CGMP is important as consumers have no mean to find out if the drug being consumed is safe and effective as testing alone is not adequate to ensure quality.Therefore, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step; in facilities that are in good condition, equipment that is properly maintained and calibrated, by employees who are qualified and fully trained, and processes that are reliable and reproducible.

Guidelines:

  • To Maintain Manufacturing facilities clean and hygienic .
  • To maintain controlled environmental conditions in order to prevent cross contamination from that may render the product unsafe for human use.
  • Manufacturing processes must be clearly defined and controlled. All critical processes are periodically validated to ensure consistency and compliance with required specifications.
  • Any Change that may affect the quality of the drug are validated.
  • Following Good Documentation practices.
  • Regular trainings of operators about the document procedures.
  • Manually or electronically maintaining of records , during manufacture that demonstrate that all the steps required by the defined procedures and instructions were followed and that the quantity and quality of drug is consistent .
  • Any deviations detected must be investigated and documented.
  • Records of manufacture and distribution so that complete history of a batch can be traced and retained and retrievable.
  • Distribution of products must minimize any risk to their quality.
  • System of Recall must be in place so as to recall any batch from sale or supply.
  • Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent its recurrence.

There are various CGMP inspections which are carried out by regulatory authorities such as FDA, EMA or MHRA. They have the goal to evaluate the degree of compliance to previously set standards of Good Manufacturing Practices. And because any research company, manufacturing organization or other institutions in Pharma must be GMP compliant, professionals working in such organizations must be able to provide proof of their eligibility, knowledge and skills. If they fail to comply with all of the requirements, they may lose their license or the product may be removed from the market.

The CFRs(Code of Federal Regulations ) of US FDA is a codification of the general and permanent rules of the federal government that relate to cGMP in the pharmaceutical and biotechnology companies are:

  • 21 CFR Part 210—Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General Part. In general, this governs cGMP for the manufacturing, processing, packaging, or holding of drugs. Part 210 includes the definitions that are used for terms in the regulations such as batch, lot, etc.
  • 21 CFR Part 211—Current Good Manufacturing Practice for Finished Pharmaceuticals. This is for finished pharmaceuticals. For example, a liquid medication leaching through a plastic container would be covered by Part 210, but a pill breaking apart after it ships likely would be covered by Part 211.
  • 21 CFR Part 600—Biological Products: General. This is related to biological products and contains key definitions, establishment standards, establishment inspection requirements, and adverse experience reporting requirements
  • 21 CFR Part 11—Electronic Records; Electronic Signatures. This contains the guidelines on electronic records and electronic signatures. Part 11 defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable, and equivalent to paper records. Part 11 also applies to submissions made to the FDA in electronic format.

Any personnel who is part of manufacturing, packaging, storing, distributing or transporting pharmaceuticals and other medical products must be trained which will equip them to understand the crucial aspects of Current Good Manufacturing Practice.

TUV India in accordance with TUV India Procedures certify for CGMP to Pharma, Food and companies providing Primary Packaging Materials to Pharma and Food Industries.