This document follows our proven practice of supplying a interactive generic document with an automatic method of populating it. Once populated, all you need to do is follow the prompts in the attached SOP. They will take you through the completion process section, by section. At the end of this process your generic document has progressed into a detailed, referenced, bespoke company document. The document follows our three level URS system that ensures functionality traceability from the URS to the various testing protocols. A great document to author and use. This document interfaces with our Validation Risk Assessment assessment (VRA), Validation Project Plan (VP), User Requirements Specification (URS), giving a seamless flow from your VMP through the VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ - VRA.

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This Matrix must sit along side your VMP or PVP and together with these documents give a very concise overall picture of your validation program. This four part matrix allows you to list all the equipment and systems that must be qualified. Each entry is allocated a row in the matrix. The row consists of eleven headings, these may be edited as required (but come with all the standard documentation titles inserted). In this matrix there is room to enter the document number, prefixed by, A to D. The document number gives you the instant cross reference to the current document, the A to D prefix shows the progress stage.


Quantity   

This Standard Operating Procedure (SOP) takes you through the validation process for equipment, from the very early first stages to the final closing stage. It will ensure that your validation is seamless, that the correct documents are raised, approved, executed, reviewed and accepted correctly. It shows how to use validation tools such as the very important matrix control document and equally important risk assessments. There are ever-increasing demands on the Biotechnology and Pharmaceutical industries to meet increasing regulatory and legislative requirements, whilst improving the performance and efficiency of the business. This SOP shows the way to streamline your validation while still being fully compliant. Easing and smoothing the production and flow of protocols, so decreasing costs and delivering validation ahead of schedule. It is essential material for the new comer to validation and will direct you flawlessly through all validation tasks. For the company it is an essential SOP to add to the library. For your convenience it is written in word.

Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11. If the spreadsheet is signed off by the user, their supervisor and QA, it becomes acceptable data stored in hard-copy, and Part 11 does not apply.

21 CFR Part 820 and 210 mandates that where the accuracy of instruments and or instrument sensors is judged as critical to the final efficacy, quality and or safety of a regulated product or could prove injurious to the integrity of any associated predicated data or data records; the individual instrument must be considered as a, “Critical Instrument”.
Critical instruments must be entered into a planned calibration program and subjected to routine calibration against master instruments traceable to national standards, at a periodicity that has a written justification. They must be placarded with a “Calibrated Label”. This SOP lists, details and defines each of the 11 essential elements of cGMP compliant calibration and calibration management. It includes sample document formats, calibration labels layouts and details the importance of the post calibration report. The SOP concludes with a fully detailed; ready to use, Calibration Manager Auditor document. This is your complete calibration SOP to purchase and use.

The cGMP Review is undertaken to ensure that a design and/or facility conforms to the cGMP requirements and is fit for purpose. The requirement for Regulatory Compliance will be established during the proposal preparation.
cGMP Reviews should normally take place in accordance with the project programme. The initial cGMP Review should take place immediately after the project initiation, to define the cGMP Envelope and clarify the cGMP requirements. Additional cGMP reviews should be held towards the end of the front end design and detailed design.
It is good housekeeping practice for department heads to instigate periodic cGMP walk rounds to analyse, document and ascertain if everyday wear and tear to the fabric of the facility, is compromising the validated status of the facility.

The ever sought after SOP for writing an SOP. Adopting a standard format throughout a company for the easy authoring of SOP's is of immense benefit to everyone that has to use them. Our format follows our standard company developed format of a generic template prefixed by an SOP. Follow the SOP and you quickly and simply produce a sound compliant SOP document. In this case the generic SOP template is prefixed by a SOP, follow the SOP and you complete your SOP. Sound confusing ! not really, just nice, easy and quick to use.

The Gap Analysis tool allows you to systematically challenge the company’s cGMP policies and procedures, comparing them with the regulatory expected standards and allowing you to draw up a list all delinquencies. Until you can highlight the company’s deficiencies, you are not able to scope the task of becoming compliant. It really is impossible to put resources together for an unmeasured task.

The purpose of producing this document in such a concise manner, is to give a desk top reference document that can be used by authors, engineers and quality staff. It can be used in meetings , during general conversation and during telephone conversations. You first check the CPR to see what rules apply, then check out the rules in depth. You can always be sure that your documents are referenced to the correct GMP requirement.

To describe the procedure for the validation of analytical methods used in the analysis of various products. The scope includes all cGMP related development, operations and support functions for the organizational units.

This Standard Operating Procedure (SOP) takes you through the validation process for software, from the very early first stages to the final closing stage. It will ensure that your validation is seamless, that the correct documents are raised, approved, executed, reviewed and accepted correctly. It shows how to use validation tools such as the very important matrix control document and equally important software risk assessments. There are ever-increasing demands on the Biotechnology and Pharmaceutical industries to meet increasing regulatory and legislative requirements, whilst improving the performance and efficiency of the business. This SOP shows the way to streamline your validation while still being fully compliant. Easing and smoothing the production and flow of protocols, so decreasing costs and delivering validation ahead of schedule. It is essential material for the new comer to validation and will direct you flawlessly through all validation tasks. For the company it is an essential SOP to add to the library. For your convenience it is written in word.

This test script has been designed to verify whether a system or a specific piece of equipment conforms with the requirements detailed in Part11. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.

The FDA has raised the bar. The rationale for change, the approach it has taken and the progress achieved are not as good as some think. In September 2003, The Wall Street Journal published an article informing all that practically all the manufacturing techniques in use in the pharmaceutical industry lagged behind those of potato-chip and laundry-soap makers. The same article correlated the rise in recalls with quality problems and noted that despite fines in excess of US$500 million for manufacturing failures, acceptable levels of quality were not being achieved.
Since then, the FDA, and the industry have been actively, working together to shape the new quality requirements and standards. Compliance now requires a quality systems approach starting with - quality by design - in development and ending with scientific process control in manufacturing. So today, products are more complex; cash is scarcer; and quality requirements require more fundamental understanding. Pharmaceutical companies need to take action on each of these issues in a comprehensive manner.