A Brief Guide to GMP Guidelines

Where is GMP Commonly Used?

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. These guidelines are often set for the creation of the following:

• Pharmaceutical products and equipment
• Food products
• Cosmetics
• Buildings

Additionally, depending on the country and industry, there are also GMP guidelines in place for companies providing the following services:

• Pest control 
• Manufacturing, assembling, and producing items for human use and consumption
• Laboratory work
• Agricultural management
• Cleaning and disinfection of work areas

GMP Guidelines and Basic Concepts

GMP guidelines are customarily flexible, with countries having their own legislation to comply with local GMP guidelines and principles. But almost all regulations are derived from the basic concept and guidelines, which are:

Quality management

Quality management, control, and assurance are essential to complying with GMP, as they ensure that manufactured products are fit for their intended use, comply with requirements, and don’t place consumers at risk due to inadequate safety, quality, or efficacy measures. All these aim to mitigate the risks that are inherent in the production process.

The basic quality management requirements stated by the World Health Organization (WHO) state the following:

• All manufacturing processes should be clearly defined, systematically reviewed in the light of experience, validated, and shown to be capable of consistently manufacturing products of the required quality and complying with their specifications and/or marketing authorization.
• All necessary facilities for GMP should have the following:
  • appropriately qualified and trained personnel;
  • adequate premises and space;
  • suitable equipment and services;
  • correct materials, containers, and labels; and
  • approved procedures and instructions.
• Instructions and procedures should be written in a clear and unambiguous language, specifically applicable to the facilities provided.
• Manufacturing tasks should be recorded to document that all required and defined steps are followed and that the quantity and quality of the product are as expected. Any significant deviations are fully recorded and investigated.
• All records of manufacture, distribution, and product history should be stored in an accessible form.
• The distribution (wholesaling) of the products should be done in a way that does not risk their safety or quality.
• A system should be available to recall any batch of product from sale or supply.
• Complaints about marketed products should be examined, and appropriate measures should be taken in respect of the defective products and to prevent re-occurrence.

Quality risk management

Quality risk management is a systematic process of assessing risks that can affect the quality of the product. This helps 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; and
• The level of effort, formality, and documentation of the quality risk management process is commensurate with the level of risk.

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 on premises

Your workplace should have an environment that is suitable for its operations and is free from risks of contamination of materials and products. The premises should also be designed to minimize errors in operations and be easy to clean and maintain.

Equipment

Similar to 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 the appropriate conditions set by the manufacturers. Manufacturers should also implement a proper stock management system 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, all personnel need to be 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 also be clear on job descriptions for each worker to avoid misunderstandings and reduce the risk of issues like overlapping responsibilities.

Validation and qualification

Critical steps in the manufacturing process should be verified to ensure that product quality is consistent and maintained at a high level. According to WHO, your qualification and validation should provide documentation stating that:

• the premises, supporting utilities, equipment, and processes have been designed following the requirements for GMP and in compliance with their design specifications; and
• the premises, supporting utilities, and equipment operate under their design specifications.

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 are an essential part of the quality assurance system and are 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.

Record each action taken for traceable activities such as manufacturing and control of products. Below are the general requirements for documentation:

• Documents must be designed, prepared, reviewed, updated, 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 not be handwritten.

Any corrections made to a document or record must be signed and dated. The reason for the correction should also be recorded (where appropriate).

Inspections and 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. Similarly, 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.

How to Comply with These Guidelines

Meeting GMP standards helps the organization comply with legislative orders, increase the quality of their products, improve customer satisfaction, increase sales, and earn a profitable return on investment. Generally, you can ensure your organization meets GMP guidelines through the following:

• Conducting performance reviews
• Staying updated on your industry’s and locality’s GMP guidelines
• Documenting all tasks, issues, and changes
• Training workers for proper compliance

You can do all these with the help of GMP compliance software, particularly one that offers GMP audit checklists and similar forms. These documents help improve the overall performance of different systems and standardize tasks to ensure compliance across all levels of your organization.

The ideal GMP compliance software will also have other features that can help with overall compliance with GMP guidelines. These can help improve operations as well, streamlining work for many. Some of these features include:

• Scheduling inspections and audits
• Training modules
• Communication channels
• Integrations with other work software
• Instant notifications for changes and issues