What is GMP?1月 7, 2021 2021-11-17 5:33
What is GMP?
What is GMP?
“Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Good manufacturing practice (GMP) guidelines apply to the activities of raw material suppliers, manufacturers, and regulatory bodies in all countries. GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. It is designed to minimize the risks involved in manufacturing pharmaceutical products, which cannot be eliminated through testing the final product. GMP aims at ensuring that products are consistently produced and controlled to appropriate quality standards…
“In recognition of the fact that all firms do not have equal resources, GMP regulations require that firms take into account their individual circumstances when implementing GMP. Aspects of GMP that relate to quality risk management can be supported by reference to the risk management of other quality system elements (e.g. HACCP).
The extent and depth of procedures necessary in this respect will depend on the type and complexity of the product, its active ingredients and their impurities, the associated risks for patients, environmental safety factors, local legal requirements, and individual firm conditions.
GMP requirements :
1. Quality Manual
2. Specifications of Active Pharmaceutical Ingredients (API)
3. Specifications of In-Process Materials (IPM)
4. Specifications of Finished Products (FP)
5. Production and Process Records that meet the approved specifications for each product manufactured
6. A system to ensure that the quality records are reviewed and updated when necessary.
7. A HACCP program for the entire facility
8. Written instructions for employees on how to start and maintain the GMP system at all levels of the facility or organization.
9. Supplier’s Certificates for Active Pharmaceutical Ingredients (API) and In-Process Materials (IPM)
10. Containment of GMP and CAPA records, controlled access to these records, and the ability to trace back each record to the original source.
11. Record retention periods of at least 10 years after current products have ceased manufacture or 15 years after the date of approval, whichever is longer(for US FDA).
12. A biocontainment program for each facility.
13. Good Laboratory Practice (GLP) for all Non-Clinical Studies
14. A system to ensure that no adulterated, misbranded, or improperly stored finished products are released from the facility.
“The owner of a pharmaceutical product is responsible for ensuring that the product is manufactured in accordance with GMP regulations applicable to the product.
“Compliance with GMP is verified through inspection of the manufacturing facility by regulatory authorities and self-inspection by the manufacturer. Regulatory authorities may withdraw or recall products from the market if they do not meet GMP requirements. Self-inspection and third-party audits are other means of ensuring compliance with GMP.
How to be GMP Complaiant?
1. Make sure to acquire GMP training before starting manufacturing. All of your employees must be trained in GMP principles, policies, and procedures. The quality manager or someone designated by the owner of the facility should ensure that all employees comply with GMP policies and procedures.
2. Establish a record-keeping system to maintain records throughout the manufacturing process, from incoming inspection through shipping and disposal of the finished product. This will include records of product movement through the manufacturing process, time of manufacture, and dates, and lot numbers of raw material usage.
These records would also include instructions from supervisors for the proper operation of GMP-compliant equipment.
3. Ensure that all employees are capable of following all policies and procedures as specified in your Quality Manual; this includes annual revalidation training for every employee in your facility. The quality manager or someone designated by the owner should ensure that all employees adhere to your Quality Manual provision about annual training every year.
4. Provide adequate training for all employees so that they understand the importance of GMP and its importance in food, drug, and cosmetic (FDC) manufacturing. Ensure that you maintain records of training sessions for each employee and provide these records to regulatory authorities or FDA upon request.
5. Maintain a detailed Quality Manual which provides in-depth details of GMP requirements, and illustrates how to implement these requirements under the specific conditions of your facility.
6. Maintain records showing that all employees are performing functions and duties which conform to GMP guidelines at all times.
7. Maintain a written procedure for each personnel procedure that describes who performs what duties, when, how often, and for how long; these procedures should be reviewed annually by the quality manager or quality assurance department head(s) and by the regulatory authority for each facility.
8. Establish systems for reviewing GMP records at least once every two weeks; review of records should include an evaluation of whether the records are complete and correct throughout their life cycle manufacturing process, with special attention to the following:
a) Records related to incoming inspections (including unannounced on-site inspections).
b) Records related to manufacturing operations (including copy sampling and labeling).
c) Records related to product release from manufacturing (including shipping information).
d) Records related to product return from the distribution channel(s).
e) Records related to product disposal through either destruction, return to the supplier of origin, or through the sale.
f) Records related to the action taken upon discovery of an adverse event that has occurred during manufacturing, distribution, or disposal.
9. Provide a written response from quality control and/or the regulatory authority on the GMP records review. Make sure that the records show that adequate attention has been given to all GMP requirements. Upon submission of your quality control responses (supporting documentation is available upon request), regulatory authorities may require direct audits and inspections within 30 days thereafter by independent third parties if they believe that you are not in compliance with GMP requirements.
10. Maintain a backup system to back-up the computerized quality records; these systems should be accessible at all times to quality control and regulatory authorities.
11. Make sure that all employees of your facility demonstrate a commitment to GMP, regardless of whether a regulatory authority is conducting an inspection or audit of your facility. The commitment to GMP must include adherence to policies and procedures, the timely response when deviations are discovered, and documentation in-depth with correct procedures regarding the implementation of corrective action(s).
12. Have a written policy and procedure for any deviation from normal manufacturing practices and at each stage of manufacture, distribution, and disposal; provide justification for deviations from the standard operating procedure (SOP).
13. Implement systems that will minimize the risk involved in the production (e.g., process validation) including but not limited to: methods, equipment, facilities (e.g., multiple-use equipment), management (e.g., training), etc.; do this upfront before the product is ever released into the distribution channel(s).
14. The person designated by the owner of the facility should conduct a risk-based analysis of your facility on a regular basis to determine if systems are in place to minimize the risks involved in production; make sure that this risk-based analysis is documented and kept for at least 7 years.
15. Keep all records related to CAPA, CCP’s, deviations, corrective actions or preventive actions, and follow-ups from periodic audits; make sure that these documents remain available for the regulatory authorities upon request(s).
16. Any changes made to your GMP procedures or SOP’s must be documented in your Quality Manual before implementation and must be approved by the quality manager or someone designated by the owner of the facility; document the date(s) of approval by regulatory authorities(s) and keep this documentation for at least 10 years after current products have ceased manufacture or 15 years after approval date depending on which comes first (for US FDA).
17. Make sure that your Quality Manual is available to all employees at all times
In conclusion, GMP ensures that products are consistently produced and controlled to appropriate quality standards. It is designed to minimize the risks involved in manufacturing pharmaceutical products, which cannot be eliminated through testing the final product.
“The regulations are very specific with regard to how you can control risk in the manufacturing process. The greater the risks associated with a particular process step or facility, the greater the level of detail required in your quality manual for that process.”