Pharmaceutical Templates

  • The Validation Toolkit is the answer to those who are either new to Validation, or those who want a simplified start to a validation approach. Pharmi Med Validations have used all their experience to piece together the essential components of a successful Validation system for both Medical Device and the Pharmaceutical industries; this toolkit will work.

    A 16-page preview of the Validation Toolkit is available here:

  • For each validation you will need to document how you plan to approach your validation, the strategy and the rationale behind your decision for the approach. There must be clear and well documented evidence for this.

    A 3-page preview of the Validation Plan Template is available here:

    You may purchase the full 10 page document in convenient Microsoft Word format including instructions for use below.

  • The URS (User Requirements Specification) is a document that indicates what your requirements are so that the supplier is clear from the outset as to your specifications of purchase.

    A 4-page preview of the User Requirement Specification Validation Protocol is available here:

    You may purchase the full 12 page document in convenient Microsoft Word format for use below.

  • A preview of the the IOQ protocol is available here:
    You may purchase the full 27 page document in convenient Microsoft Word format including instructions for use below.  
  • The Tablet Counter IOQ template is a versatile template for basic filling machines with less complexity of material handling, and without a vision system.

    A preview of the IOQ protocol is available here:

    You may purchase the full document in convenient Microsoft Word format including instructions for use below.

  • This summary should be documented and archived with the rest of the Validation.

    Upon this stage the equipment will be handed over to production.

    A 3-page preview of the Summary Report is available here:

  • As part of your manufacturing procedure you must have Standard Operating Procedures to ensure that all stages of the process of manufacture is standardised under a controlled document that is easy to follow which can be assisted with aid of visual diagrams or photos.

    A 2-page preview of the SOP Template is available here:

  • The Shearer/In Line Mixer IOQ template is a versatile template for basic machines with less complexity of material handling.

    A preview of the IOQ protocol is available here:

    You may purchase the full document in convenient Microsoft Word format including instructions for use below.

  • To comply with 21 CFR part 11 Electronic Records & Signatures, you will need to ensure that your records and data which holds any quality critical information will require validation and verified.

    A preview of the the IOPQ Validation Protocol is available here:

    You may purchase the full 10 page document in convenient Microsoft Word format including instructions for use below.

  • The Liquid Filler IOQ template is a versatile template for filling lines, and without a vision system. A preview of the the IOQ for Validation Protocol is available here:
    You may purchase the full 27 page document in convenient Microsoft Word format including instructions for use below.
  • This is a combination of the IQ, OQ and PQ. You can use this for a full qualification, add or remove any sections as you require.

    A 5-page preview of the Installation, Operational and Performance Validation Protocol is available here:

    You may purchase the full 35 page document in convenient Microsoft Word format including instructions for use below.

  • The Laminar Air Flow IOPQ is essentially a Installation and Performance Qualification with a rationale for OQ, where is most systems there are no settings to challenge that can affect the overall integrity of performance.

    A preview of the the IOPQ Validation Protocol is available here:

    You may purchase the full 25 page document in convenient Microsoft Word format including instructions for use below.