GMP Certificate refers to a system for ensuring that products are consistently produced and controlled by quality standards. It’s intended to reduce any production-related risks that can’t be eliminated by testing the final product.
If GMP is not followed, the following risks arise:
unexpected product contamination resulting in health or even death
Incorrect labeling on containers resulting in patients receiving the wrong medicine
Insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.
Beginning materials of poor quality
Inadequate sanitization and personal hygiene among staff
Inadequate employee training lead to non confirming products
Missing procedures to be followed in critical sections will lead to non confirming product and or impact on the final product’s quality.
Based on WHO GMP, various countries have developed their own GMP requirements.
Many Certification Bodies (CB) and third-party inspection agencies are authorized to visit and audit your facility and Issue GMP Certificate.
The following are the core topics covered in a GMP Audit.
Is the product produced and distributed in such a way that any risk to their quality is minimized?
Manufacturing facilities, including laboratories and storage, is maintained a clean and hygienic environment.
What is established to prevent cross-contamination of products, as well as cross-contamination from labeled or unlabeled material or products,
Is the manufacturing facility design suitable for production?
Are the environmental conditions are controlled?
Is the manufacturing process well defined to ensure consistency and compliance with specifications,
Is the manufacturing processes validated and controlled?
Any changes to the manufacturing process are assessed for patient safety/product quality, and any approved change that may affect the quality is qualified or validated as needed.
Is the language used in instructions and procedures must be unambiguous.
Are the operators are trained to follow documented and approved procedures when producing and inspecting products.
During manufacturing and quality control, records should be kept to show that all of the steps required by the defined procedures and instructions were followed to the letter and that the products’ quality attributes were met.
Deviations are looked into and recorded. Valid GMP Audit point!
The manufacturing and distribution records are kept in a readable and accessible format that allows a batch’s complete history to be traced during the shelf life plus one year period.
GMP Certificate and Role of GMP Consultants
Facility Audit and GAP assessment
Understanding your activities and planning for certification
Identify and draft necessary procedures
Identify and draft necessary templates according to procedures