Commissioning & Validation
Biopharmax group has many year of experience with installation, commissioning and qualification procedures for pharmaceutical facilities, as it is an essential part of GMP.
Biopharmax group provides services of protocol preparation as well as tests execution of site.
The pharmaceutical and therapeutic industry is committed by the regulation authorities to produce its products using validated systems, equipment and processes. Validation is a documented procedure for the process of checking if something satisfies a certain criterion determined in advance. Biopharmax provides documented evidence that the systems or equipment has been installed and works according to the customer demands.
Biopharmax’s validation approach is primarily based on ISPE FSE and ASTM E2500.
Validation is done by Biopharmax team during all stages of the project from start to finish:
1. Early planning stage.
• DQ – design qualification.
2. Installation stage
Commissioning: A well planned, documented, and managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the End-User that results in a safe and functional environment that meets established design requirements and stakeholder expectations. (ISPE baseline)
• IC – installation commissioning.
i. Detailed and documented testing of every installation detail in the system
ii. Recorded on “stand alone” lists not part of the IC protocol
• OC – operation commissioning.
i. Detailed and documented testing of every operational detail in the Functional Specs
ii. System/Equipment operational tests recorded on “stand alone” lists not part of the OC protocol
3. Post construction stage
• IQ – installation qualification.
i. Detailed and documented listing of GMP installation details in the system
ii. Inspection of commissioning generated “stand alone” lists
• OQ – operation qualification.
i. Detailed and documented testing of process operational detail in the Block Diagram / main performance parameters
ii. System/Equipment operational listing of commissioning generated “stand alone” lists not part of the OC protocol
iii. Inspection of commissioning generated GMP “stand alone” lists
iv. Clean room testing according to ISO 14644 + Annex A (tests including: Filter Air Velocity and Uniformity Test. Flow Rate & Air Changes test, Filter Integrity test, Particles counting Test(ISO 14644-1: 2015), Room Recovery Test (particles), Room Recovery Test (pressures), Lighting & Noise Test, Air Patterns Test (Smoke Tests).
• PQ – performance qualification
i. Tests during at rest, and in operation.
ii. Tests such as settling plates, contact plates, Mass 100, particle tests etc.
iii. Risk assessment document (for microbiology and particle tests)
iv. SOP for cleaning procedure, check list etc.
v. Temperature mapping for storage/cold rooms etc.
• Cleaning Validation
i. VMP – Validation Master Plan (for API, Detergent and Micro.)
ii. Cleaning Validation Protocols and reports
iii. Matrix
iv. Limit Calculation and rational
v. Grouping
vi. Surface Area Calculation
vii. Status
viii. Annual Review
ix. Deviations
• Process Validation (PPQ)
i. VMP – Validation Master Plan (for Solids, semi solids, liquids and sterile)
ii. Process Validation Protocols and reports
iii. Data processing
iv. Statistical tools
v. Implementation of the New Validation Guide (FDA)
vi. Status
vii. Annual Review
viii. Deviations
