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. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made. WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.
is GMP necessary if there is a quality control laboratory?
Yes. Good quality must be built in during the manufacturing process; it cannot be tested into the product afterwards. GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.
Costing of GMP: Can manufacturers afford to implement GMP?
Yes. Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.
WHO works to strengthen GMP
WHO GMP guidelines are available online. If you require more information, please contact the WHO representative in your country, your WHO regional office or WHO headquarters in Geneva.
Benefits of GMP Certification :
- Improves brand value or image in the market
- Provide guideline on how to produce safe and quality products.
- Develops customer satisfaction by deliver the safe and quality product and services.
- Develops motivation and team work between the employees of the organization.
Process to get the GMP Certification :
- Application : This is the first step to get the GMP certification, the application covers some basic information of the company. The certification body must accept the application and needs to b record or maintain all the information on the GMP database.
- Review of Application : The application received shall be reviewed by the team to ensure that the compliance requirement have been fulfilled.
- Quote and Agreement : After the review of documents we provide the price quotation to the client and performs the Gap Analysis to cover all the clauses and section of the quality standards and Gap Analysis is done to check the Gap between companies planned things and achieved things.
- Documentation Review : Check the document of the organization to ensure that the documentation fulfilled the compliance requirement.
Stage – 1
- Audit : Evaluate your organizations documented procedure and policies against the compliance requirement.
- Review : Review the documentation of your management system to ensure that the compliance requirement have been contented.
- Corrective Action : Corrective action is deal with the non-conformity. It has taken when the non-conformity occurs.
- Verification : Verify the documentation of the organization as per the standard requirements.
Stage – 2
- Audit : In stage-2 audit, the auditor verifies that the organization implement according to its documentation and if the auditor of certification body identifies the non-conformities then the auditor give the opportunity to correct the non-conformities.
- Review : Review the implementation process according to the organizations document.
- Corrective Action : If there is any non-conformity occurs then the corrective action has been taken.
- Verification : Verify work instruction and implementation process are being followed by your employees.
- Granting of Certification : The Certification Body will issue a certificate of compliance, which is valid for three years.
- Surveillance Audit : Surveillance audit conduct to ensure that the organization meets the requirements of the management system. Surveillance audit must be performed in every six month or one year from the date of issued certificate.
- Re-Certification : Re-certification is the process, which is done at the end of three years period.
- Review : Review the documentation and implementation process of your management system to ensure that the compliance requirement have been contented.
- Corrective Action : Recheck the non-conformity, if any other problem occurs then CB give the opportunity to the organization to resolve the non-conformity.
- Verification : Compare the documentation of the organization with the compliance requirement