Regulatory compliance

Regulatory compliance

Reports & documentation

To enable the client’s internal quality standards to be upheld, Enbloc have realised the importance of producing high quality reports and validation documents, which will provide the client with evidence of the continued performance of the facility.

The documents Enbloc provide give a clear and comprehensive guide to the current standard of the facility. Detailed methodology, Acceptance Criteria, Results and Summary Conclusions are provided, along with all relevant supporting documentation including facility drawings, calibration certificates, equipment and location reference drawings and raw data collected during the validation exercise.

Cleanroom facility

Regulatory standards

Enbloc can design and build your facilities to comply with such regulatory standards as:

BS EN ISO 14644 – Range of cleanroom standards that is produced by the International Organization for Standardisation (ISO).

Fed 209E. This has now been superseded by the ISO 14644 family of documents.

Other guidelines include:

  • cGMP Guidelines
  • GLP Guidelines
  • MHRA Approvals
  • ACDP Guidelines
Exhaust pipes

Protocols

For any new or modified cleanroom facility, Enbloc understand that it is essential to have a structured system in place to ensure your facility is designed, built and performs to the required standard.
Enbloc can assist in the production of User Requirement Specifications and the following essential documents:

  • Design qualification (DQ) Used to provide documented evidence that the proposed design of the facility meets with the user requirements and cGMP.
  • Installation qualification (IQ) Gives the documented evidence that the facility has been installed in accordance with the agreed design.
  • Operational qualification (OQ) Provides evidence that the installation operates as specified and within the agreed specification parameters.