GMP guidelines are a set of principles that help manufacturers implement an effective manufacturing process and ensure that quality is built into the organization and the processes involved. GMP guidelines are customarily flexible, with ries having their own legislation to comply with local GMP guidelines and principles. But almost all regulations are derived the basic concept and guidelines which are:
Quality management
The principle of quality management is to ensure that manufactured products are fit for their intended use, comply with requirements, and does not place consumers at risk due to inadequate safety, quality, or efficacy measures. To achieve this quality objective, quality assurance, good manufacturing practices, quality control, and quality risk management should be comprehensively and correctly implemented.
- Quality assurance – The system of quality assurance aims to ensure that manufactured products are designed and developed in a way that meets the requirements for Good Manufacturing Practice.
- Good Manufacturing Practice for Products – As a part of quality assurance, good manufacturing practice is concerned with production and quality control. It aims to mitigate the risks that are inherent in the production process. Its basic requirements according to WHO’s Good Manufacturing Practices for Pharmaceuticals state the following:
- All manufacturing processes are clearly defined, systematically reviewed in the light of experience, and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specifications and/or marketing authorization;
- Critical steps of manufacturing processes and significant changes to the process are validated;
- All necessary facilities for GMP are provided including i. appropriately qualified and trained personnel; ii. adequate premises and space; iii. suitable equipment and services; iv. correct materials, containers, and labels; v. approved procedures and instructions;
- Instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided;
- Operators are trained to carry out procedures correctly;
- Records are made, manually and/or by recording instruments, during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product were as expected. Any significant deviations are fully recorded and investigated;
- Records of manufacture including distribution which enable the complete history of a batch to be traced are retained in a comprehensible and accessible form;
- The distribution (wholesaling) of the products minimizes any risk to their quality;
- A system is available to recall any batch of product, sale or supply;
- Complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures are taken in respect of the defective products and to prevent re-occurrence
- Quality control – Quality control is a part of Good Manufacturing Practice that focuses on sampling, specification, and testing. It checks the organization, documentation, and release procedures to ensure that products go through the required tests before being released for sale or supply.
- Quality risk management – Quality risk management is a systematic process of assessing risks that can affect the quality of the product. According to its principles, quality risk management should ensure that:
- The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient and users;
- The level of effort, formality, and documentation of the quality risk management process is commensurate with the level of risk. c) The general quality risk management process and integration into the product quality can be referred to in ICHQ9.
Sanitation and hygiene
Sanitation and hygiene are vital in every aspect of the manufacturing process. It covers anything that can cause contamination such as personnel, the premises, equipment, containers, and production materials. All potential sources of contamination should be identified and eliminated with a comprehensive sanitation and hygiene program.
Building and facilities/premises
As a principle, the premises should be situated in an environment that is suitable for its operations and one that is free risks of contamination of materials and products. The premises should also be designed to minimize errors in operations and should be easy to clean and maintain.
Equipment
Same with the premises, equipment should be designed, located, and maintained to function according to its intended use. Additionally, it should be cleaned and stored according to procedures. In the event of a defect or malfunction, it should be removed or labeled as defective.
Raw materials
All materials used for production should be stored properly according to its appropriate conditions which are set by the manufacturers. There should be a proper stock management system implemented to ensure that all incoming materials are correct and of high quality.
Personnel
The success of GMP compliance heavily relies on the people implementing it. For this reason, it is vital that all personnel are qualified and trained to do the job. They should be aware of the principles of GMP and receive continued training, hygiene instructions, and other tools relevant to their needs. Respective managers should be clear on job descriptions for each worker to avoid misunderstandings and reduce the risk of issues like overlapping responsibilities.
Validation and qualification
Qualify systems, premises, and equipment if they are fit/ready for their intended use and validate if processes and procedures can repeatedly produce high-quality products. Critical steps in the manufacturing process should be verified to ensure that product quality is consistent and maintained at a high level. According to the WHO (World Health Organization), qualification and validation should establish and provide documentation stating that:
- the premises, supporting utilities, equipment, and processes have been designed in accordance with the requirements for GMP (design qualification or DQ)
- the premises, supporting utilities, and equipment have been built and installed in compliance with their design specifications (installation qualification or IQ);
- the premises, supporting utilities, and equipment operate in accordance with their design specifications (operational qualification or OQ); and a specific process will consistently produce a product meeting its predetermined specifications and quality attributes (process validation or PV, also called performance qualification or PQ)
Complaints
Handling complaints is also part of GMP, therefore all manufacturing companies should have a well-designed GMP complaint system. Ideal complaint handling should have a ready solution to provide for all contingencies.
Documentation and recordkeeping
Good documentation and recordkeeping is an essential part of the quality assurance system and is required in compliance with GMP requirements. Accurate recordkeeping can help managers and supervisors keep track of the historical record of manufacturing procedures and corrective measures implemented. Below are general requirements for documentation:
- Documents must be designed, prepared, reviewed, and distributed with care.
- Documents should be clear and legible.
- Documents must be approved, signed, and dated by appropriate and authorized personnel.
- Documents must have unambiguous contents such as title, nature, and purpose.
- Documents must be regularly reviewed and updated.
- Documents must not be handwritten.
- Any corrections made to a document or record must be signed or initialed and dated. The reason for the correction should also be recorded (where appropriate).
- Record each action taken for traceable activities such as manufacturing and control of products.
Inspections & quality audits
Inspections should be regularly performed to monitor if GMP is implemented and complied with. Document what areas need more work and provide corrective measures for continuous improvement. Quality audits are done to assess the quality systems implemented by the manufacturing company. GMP audit checklists can help companies comply with GMP guidelines set by regulatory authorities. By performing site visual walkthroughs and conducting manufacturing evaluations, you can identify non-compliant processes and take immediate action to address areas for improvement.
