GMP WHO Certification
Good manufacturing practice (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 & Food production that cannot be eliminated through testing the final product. 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. 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. WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.
GMP covers all aspects of the manufacturing process including :
- Defined manufacturing process
- Validated critical manufacturing steps
- Suitable premises, storage, transport, qualified and trained production and quality control personnel
- Adequate laboratory facilities
- Approved written procedures and instructions
- Records to show all steps of defined procedures have been taken
- Full traceability of a product through batch records and distribution records
- Systems for recall and investigation of complaints
GMP WHO For Whom
- Business organization with pharmaceutical objectives
- Medical device manufacturers
- Food products manufacturers
Benefits of GMP WHO Certification
- Improves brand value or image in the market
- Provide guideline on how to produce safe and quality products.
- Develops customer satisfaction by deliver the safe and quality product and services.
- Develops motivation and team work between the employees of the organization.