About GMP Compliance

Good Manufacturing Practice (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 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 below. 

In particular, the GMP principles intend to provide a secure manufacturing environment that protects raw data from manipulation during and after procedures and incorporates all organizational structures of manufacturing procedures. Therefore GMP not only regulates the personnel working in a laboratory or other manufacturing facility, but also applies to computerized systems and their device-specific requirements used for manufacturing purposes.

As a result, computerized systems like Labstep have to provide validated services to ensure accuracy, reliability and consistent intended performance, including the ability to ensure data quality and integrity, protecting stored records against manipulation or loss. Since the compliant adherence to GMP is not exclusively based on the software system itself but also depends on procedural controls (such as SOPs, well trained personnel, physical conditions of manufacturing facilities) within a laboratory or other organizations using electronic management systems for manufacturing purposes, a software system cannot be certified to be compliant (and any software vendor claiming GMP-compliance is incorrect!).

This document summarizes the basic GMP principles and how the Labstep platform enables compliance with these requirements. Guidelines that are enabled and supported by Labstep’s features and functionality are indicated in green. 

Quality management

The principle of quality management is to ensure that manufactured products are fit for its intended use, complies 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;
  • Labstep protocols can help you meet this requirement. Steps to be carried out can be marked clearly and unambiguously within the protocol.
  • 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;
  • Steps in Labstep protocols can be marked as complete each time they are performed. A time stamp is recorded with the date / time of completion.
  • Records of manufacture including distribution which enable the complete history of a batch to be traced are retained in a comprehensible and accessible form;
  • Interactive slots for materials can be added to protocols so that each time a protocol is run you can link it to the specific inventory items used / produced in that run - allowing the history of batches to be traced.  
  • The distribution (wholesaling) of the products minimizes any risk to their quality;
  • A system is available to recall any batch of product, from 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 is 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 from 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 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.

  • Labstep allows you to track the individual batches of all resources along with the amount remaining in each batch. Notes and metadata can be added to each batch so that all important information is captured and quality can be tracked. 

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 its 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.
  • Labstep protocols are version-controlled, allowing you to track how a procure has changed over time. Labstep allows you to control view / edit access permissions to protocols and experimental records.
  • Experimental records on Labstep can be reviewed, electronically signed and locked by multiple parties. 
  • Documents should be clear and legible.
  • Labstep protocols allow procedures to be outlined in a clear and easy-to-follow format.
  • Documents must be approved, signed, and dated by appropriate and authorized personnel.
  • Timestamps: records and changes are provided with a system-created timestamp, recording person, date and time. These timestamps are in-editable by users. 
  • All activity associated with Labstep experiment records and protocols is tracked in an activity log.
  • Experimental records on Labstep can be reviewed, electronically signed and locked by multiple parties. 
  • Documents must have unambiguous contents such as title, nature, and purpose.
  • Labstep experiment entries offer standard fields such as title, description for this purpose. 
  • Labstep protocols have a standard title field and are suitable to outline contents such as nature and purpose
  • Documents must be regularly reviewed and updated.
  • Labstep protocols are version-controlled, allowing you to track how a procure has changed over time.
  • Documents must not be handwritten.
  • Nature of a digital platform
  • Any corrections made to a document or record must be signed or initialed and dated. Reason for the correction should also be recorded (where appropriate).
  • Timestamps: records and changes are provided with a system-created timestamp, recording person, date and time. These timestamps are in-editable by users. 
  • Experimental records on Labstep can be reviewed, electronically signed and locked by multiple parties. 
  • Labstep protocols are version-controlled, allowing you to track how a procure has changed over time.
  • Record each action taken for traceable activities such as manufacturing and control of products.
  • Labstep experiment records allow tracking of complete manufacturing procedures and end-to-end workflows.
  • All activity associated with Labstep experiment records and protocols is tracked in an activity log.

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.

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