Information & Training. | Quality Assurance. Quality Management.

What is cGMP – Current Good Manufacturing Practice

cGMP refers to “current good manufacturing practice”. Good manufacturing practices are implemented across product development, processing and end use of medical type products to ensure the delivery of a compliant, effective, conforming (to specification), consistently high quality product. Good Manufacturing Practice requirements are enforced by regulatory bodies when assessing the ability of a manufacturer to consistently output product, that can achieve the medical benefit claims associated with their products. cGMP spans the entire development and supply chain, from product development including clinical trial feedback, through raw material selection and sourcing, process development, qualification and validation, product release, distribution and use, including the gathering and analysis of customer use data.

cGMP is applied by regulatory bodies in industries such as medical devices, pharmaceutical, food, bio-technology, i.e. those industries where a product or process failure, or deficiencies with the constituent materials, failings within product formulation or within the manufacturing process, etc. can lead to human injury.

Documentation
CAPA – Corrective And Preventative Action
Calibration Certification
Good Manufacturing Practice (GMP)
Change Management and Control
Quality Management Training
Product and Process Validation
Supplier Quality Assurance
Audits & Auditing
Ensuring the Quality Management System is Risk based
Etc. …. Etc. …. Etc. …
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The scope of the Good Manufacturing Practices.

The GMP’s cover the total range of activities necessary to assure product quality. For example before a product can be manufactured, are there clearly defined specifications and operating procedures in place? Have all relevant staff been trained on the procedures within their area that have a potential impact on product quality? Are there defined records management processes and storage controls in place? Is product and process change management defined and consistently applied. Before change is effected are validation requirements assessed?

For raw materials, are there approved material specifications, are there defined incoming inspection tests or other controls in place? If raw material is found to be non-conforming are there procedures in place for segregating, holding and disposition of this raw material? Similarly, throughout the manufacturing process are there defined test and inspection points? Are the results of any non-conformances documented, trended, reviewed and appropriate corrective and preventative action taken to address and prevent further repeat failures? When product is used by a customer, are there effective feedback processes in place, so that the customer can communicate back to the manufacturer with any product complaints or information of adverse incidents with the use of the product? Is the manufacturer actively reviewing such feedback and using to improve product quality going forward?

Objective of the GMP’s.

As can be seen from the above, the GMP’s seek to ensure that all manufacturer’s of regulated products effectively implement a range of manufacturing controls over the development and manufacture of products, with the objective of ensuring that process outputs are of the highest quality and consistently remain so over time.

The GMP’s themselves are not prescriptive. There are broad categories of requirements which a manufacturer must adhere to, however, the specific methods of implementation may vary from one manufacturer to another. For example, there must be document control and document revision processes in place to comply with the GMP’s. However, each manufacturer will define their own document control and revision process. The regulatory body can then review the effectiveness of these procedures via audit.

What is the “c” in the cGMP’s.

The cGMP refers to current GMP. The regulatory bodies who enforce the GMP requirements, expect that manufacturers will continually improve their quality systems. As technology and best practice improves, then what is acceptable today may be deficient in some manner tomorrow. The “c” indicates that in order to comply with the GMP’s, manufacturers need to be aware of changes within their industry and ensure that they continually adopt and improve their quality systems to meet “current” best practice.

Information & Training.

Medical Device:

- - Validation. Classification. Regulation. Requirements. Current best practices.
  - FDA cGMP’s. EU MDR’s / MDD’s.
  - FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
  - FDA Medical Device Classification. The FDA approach to Medical Device Classification.
  - EU Medical Device Regulation and Classification (per MDD’s).
  - ^NewEuropean Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
  - Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
  - Quality System requirements to maintain compliant Validations.
  - Etc. Etc. …
  - Information & Training presentation >>>

Information & Training. | Quality Assurance. Quality Management.

- - - Documentation
    - CAPA – Corrective And Preventative Action
    - Calibration Certification
    - Good Manufacturing Practice (GMP)
    - Change Management and Control
    - Quality Management Training
    - Product and Process Validation
    - Supplier Quality Assurance
    - Audits & Auditing
    - Ensuring the Quality Management System is Risk based
    - Etc. …. Etc. …. Etc. …
    - Information & Training presentation >>>