Good Manufacturing Practice - GMP is a term that is recognized worldwide for the control and management of manufacturing, testing and overall quality control of food and pharmaceutical products. GMPs have been used by the pharmaceutical and healthcare manufacturing industries for over 50 years as a means of assuring that products have the identity, strength, purity and quality that they purport to contain. GMPs are in effect in over 100 countries, and GMP compliance is a pre-requisite to exporting pharmaceuticals between countries. GMP takes quality assurance approach, which ensures that products are consistently produced and controlled according to the quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. It covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. It is believed that GMP is a good business tool, which helps to refine both compliance and performance of the company. GMP requirements are largely common sense practices, which help companies better themselves as they move toward a quality approach using continuous improvement. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors.
GMP Certification confirms the products' identity, composition, quality, purity and strength which they represent in the market. 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. GMP Certification for API (Active Pharmaceutical Ingredients) is offered by Punyam.com. It is issued by Certifying body, which is accredited to provide certificate under the GMP. The certificate is issued for the period of 3 years after successful completion of pre-assessment and registration (final) assessment. The certificate is valid till 3 years from the date of issue. Surveillance audits are conducted by the Certifying body within the period of 3 years at the interval of 9 months or 12 months, depending upon the nature and size of the organization. Upon completion of 3 years, renewal audit is done for a new 3-year cycle
Punyam.com, a leading GMP Consultancy in India, is having vast industrial experience in the implementation of GMP for all types of Pharmaceutical industries. Punyam implements the GMP certification consultancy for its customers in the following manners:
1 .Micro-level survey for each and every products of the pharmaceutical industries and preparation of detailed gap analysis report;
2. Preparation of applicable documents required by GMP, based on detailed study of all activities of the pharmaceutical industries, such as:
3. GMP training to all levels of employees within the organization,
4. Help in effective implementation of system by periodic visit, till GMP Certification;
5. Conduct internal audit to check readiness for the accreditation;
6. Conduct management review meeting in presence of Top Management to guide the organization for effective implementation on all the issues;
7. Conduct mock drill for traceability of product as well as production recall, etc.