GMP Certification Services

Good manufacturing practice (GMP)is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products and medical devices.Under it, there is a set of guidelines that offer a system of procedures and documentation by which the confirmation of the products are given.Benefits from GMP /WHO GMP:Reduced duplication of inspectionsEnhanced market accessExport facilitationCost savingsCustomers, employees, stockholders, regulators and competitors develop sustainable respect for an organization which demonstrates its proactive commitment to food safety.A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.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.
The first World Health Organization (WHO) draft text on Good Manufacturing practices (GMP) was prepared at the request of Twentieth World Health Assembly in 1967 by a Group of Consultants. The text was discussed by the WHO Expert Committee on specification for Pharmaceutical Preparations in 1968.When the World Health Assembly recommended the first version of the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce in 1969, it accepted at the same time, the GMP text as an integral part of the Scheme. The revised versions of both the certification scheme and GMP text was adopted in 1975. Since then the certification scheme has been extended to include certification of:
- Veterinary products administered to food producing animals.
- Starting materials for use in dosage form.
- Information on safety and efficacy.
The Director General of WHO invited the member States to participate in the Scheme. The Drugs Controller of India informed WHO that India had decided to participate in the certification scheme. The issue was discussed in the 20th Meeting of Drugs Consultative Committee held at New Delhi on 4th & 5th July 1978. The silent features of WHO Certification Scheme were discussed and it was decided that the inspection of firms intending export of drugs be thoroughly inspected and ensured that they observe the necessary control on quality during and after manufacture of pharmaceutical products and follow Good Manufacturing Practices before a certificate is issue in their favour.
GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.