GMP – Good Manufacturing Practice

Good Manufacturing Practice – GMPis 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

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 is given. GMP Certification for API (Active Pharmaceutical Ingredients) is offered by Niall Services. 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.

Steps involved in GMP Certification Consultancy Service:

Niall Services, is a leading GMP Consultancy in India, is having vast industrial experience in the implementation of GMP for all types of Pharmaceutical industries. Niall Services implements the GMP certification consultancy for its customers in the following manners:

1. Micro-level survey for each and every product 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:
   • GMP Manual
   • Procedures for GMP Certification (mandatory procedures required by the standard)
   • GMP Process Approach for various departments of an organization
   • Standard Operating Procedures (SOPs) for inspection of various activities as well as operation and calibration of identified equipment’s used in the inspection
   • Formats to establish the objective evidence of implementation and to ensure control over all the inspection parameter
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.

Benefits of GMP Certification

1. Minimizes the food safety hazards/ contamination in food.
2. Ensures that raw materials used in the manufacture of drugs are of known and of possibly standardized quality, and are free from contamination.
3. Ensures that the manufacturing process has been proven to produce a pharmaceutical product meeting its quality attributes.
4. Ensures that adequate quality control testing measures have been employed to assure that the product meets its quality specifications at time of release to market, and at the end of its shelf life.
5. Enables employees to develop good production / operations habits.
6. Reduces safety risk in product quality and safety.
7. Timely detects production and management problems, reduces cost.
8. Helps better understand and comply with the relevant laws and regulations.
9. Enhances the international credibility and public image.
10. Increases customer’s long-term confidence in the enterprise.
11. Helps boost export opportunities.
12. Reduces duplication of inspections