GMP

Good Manufacturing Practices (GMPs) contain both requirements and guidelines for manufacturing of food and drug products in a sanitary environment.

The Food and Drug Administration has developed GMPs for all foods, and that agency enforces those GMP for all foods except meat, poultry, and egg products. The U.S. Department of Agriculture Food Safety Inspection Service has regulatory authority for those products.

The term GMP was introduced to regulate manufacturing and packaging operations in the pharmaceutical company. Until the mid-1960s, operating procedures for the manufacture of drugs consisted of formula and the basic methods of making products.

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 or product specification.

Good Manufacturing Practices (GMP) certification ensures the integrity of your food manufacturing Process as well as your compliance with food safety regulations. Assurance of the safety and quality of food is an important consideration for consumers today. A GMP is an important enhancement to your food safety management system, which increases your customers confidence in your commitment to trading and producing safe, high quality food.

Good Manufacturing Practice (GMP) is a component of Quality Assurance which helps to ensure that medicinal products are consistently produced with the quality standards appropriate for their intended use. Under the Medicines Act, all manufacturers and assemblers of medicinal products (both "Western Medicines" and "Chinese Proprietary Medicines" (CPM)) are required to conform to GMP. As a member of PIC/S, HSAs GMP auditors will conduct audits on medicinal product manufacturers and assemblers in accordance with the PIC/S Guide to GMP for Medicinal Products (Part I) and its relevant annexes, which encompass all the recommendations of the World Health Organization (WHO) in relation to GMP.

A GMP certificate is granted when the manufacturing facility has been audited and found to demonstrate satisfactory compliance with the required GMP standard. The name and address of the manufacturing site and the scope of the certification will be defined on the GMP certificate. The scope of certification would normally be determined by the scope of the actual audit that was performed at the manufacturing facility and the types of dosage forms/range of products being manufactured. A GMP certificate would normally be valid for 3 years from the date of assessment. The certificate would be issued in the name of the local firm/company registered with the Accounting and Corporate Regulatory Authority. The person making the application should be authorized by the company to do so as the person responsible (e.g. Managing Director, QA/QC Manager, Production Manager).

GMP Certification Program" is designed to verify that manufacturing practices for dietary supplements conform to a standardized set of good manufacturing practices (GMPs) developed and approved by the Natural Products Association.

A system of quality assurance appropriate for the fabrication, packaging, labeling, testing, distribution, importation, and wholesale of drugs should ensure that Drugs are designed and developed in a way that takes into account the GMP requirements Managerial responsibilities are clearly specified; Systems, facilities and procedures are adequate and qualified; Production and control operations are clearly specified; Analytical methods and critical processes are validated; Arrangements are made for the supply and use of the correct raw and packaging materials. GMP are the part of quality assurance that ensures that drugs are consistently produced and controlled in such a way to meet the quality standards appropriate to their intended use, as required by the marketing authorization.

The Guide presents a review of the types and extent of validations required by GMP, the preparation of a Master Validation Plan, formats for the equipment and systems qualifications and process and analytical assay validation protocols, and examples of the typical requirements for various validation studies. Validation of computerized systems is not covered in this Validation Guide.

GMP