ALPI Associates implements the GMP certification consultancy for its customers in the following manners:
Micro-level survey for each and every products of the pharmaceutical industries and preparation of detailed gap analysis report;
- Preparation of applicable documents required by GMP, based on the 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 used in the inspection
– Formats to establish the objective evidence of implementation and to ensure control over all the inspection parameter - GMP training to all levels of employees within the organization
- Help in effective implementation of the system by periodic visit, till GMP Certification
- Assist in conducting an internal audit to check readiness for the accreditation
- Assisting in conducting management review in presence of Top Management to guide the organization for effective implementation on all the issues
- Conduct mock drill for traceability of product as well as production recall, etc
Practices are recommended with the goal of safeguarding the health of consumers and patients as well as producing good quality food, medicine, medical devices, or active pharmaceutical products. A food or drug may be deemed “adulterated” if it has passed all of the specifications tests, but is found to be manufactured in a facility or condition which violates or does not comply with current good manufacturing guidelines. Therefore, complying with GMP is mandatory in all pharmaceutical manufacturing, and most food processing.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing.
The quality shall be built into the product and GMP is the most essential part of ensuring this product quality.
If you are looking for GMP certification consultants in Gujarat then please contact us.