Information & Training. | Medical Devices.

FDA QSR Process Validation

Validation of processes and systems is fundamental to achieving the required Quality, Safety and Efficacy requirements. Through proper design and effective validation a product designer, developer, manufacturer or distributor can establish confidence that a product will consistently meet their product specifications.

Documentation associated with Quality System Regulation (QSR Validation) includes:

— Standard operating procedures (SOPs)
— Specifications
— Validation master plan (VMP)
— Qualification protocols and reports
— Validation protocols and reports

There should be appropriate preparation and planning before validation is performed. There should be a specific programme for validation activities. Validation should be performed in a structured way according to the documented procedures and protocols.

Validation should be performed for premises, equipment, utilities and systems, processes and procedures, at periodic intervals, and when major changes have been made.

Validation should be performed in accordance with written protocols. A written report on the outcome of the validation should be produced. Validation should be done over a period of time, e.g. at least three consecutive batches (full production scale), to demonstrate consistency. Worst case situations should be considered.

Manufacturers need to identify what validation work is needed to prove that critical aspects of their operations are appropriately controlled. Significant changes to the facilities or the equipment or processes that may affect the quality of the product should be validated.

A risk assessment approach should be used to determine the scope and extent of validation required.


FDA QSR Process Validation

Validation. Classification. Regulation. Requirements. Current best practices.
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CFR Part 820 – Quality System Regulation

Subpart G – Production and Process Controls

Sec. 820.75 Process validation.


(a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.

(b) Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.

(1) Each manufacturer shall ensure that validated processes are performed by qualified individual(s).

(2) For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.

(c) When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.


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).
      • New European 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.
      • Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
      • Medical Device Software Validation.
      • Medical Device Design Validation.
      • Electronic Signature, Electronic Records.
      • Life Cycle Approach to Validation.
      • Risk Identification. Documentation. DHR’s. DMR’s.
      • Etc. Etc. …
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