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FDA Citations and SOP's.
May 31, 2015

FDA Citation and SOP's.

Can SOP's reduce or even stopped the FDA raising citations for cGMP delinquencies? Well perhaps if the SOP is used as a whipping stick – to lash us all into a state where we will accept that repeated audits failures are bad when they are highlighted by in house audits – but can become catastrophic when highlighted by our regulators. Then surely it is time for us to repeat the in house audits until we are consistently demonstrating 100% compliance.

We have on offer today four SOP’s that cover 75% of adverse warning letter comments. We have grouped them together and are offering them at a price that they could never be individually authored and produced for. Don’t miss this offer it will not be made permanent.

To publish ready-to-use documentation would of coarse be commercial suicide; so we have left the text unintelligible. This allows you to get a feel for the quality and scope of the document whilst leaving our proprietary rights reasonably safe. Enjoy.

SOP 21 CFR Part 11 Compliance.

Recent guidance documents have changed certain aspects of the Part 11 requirements. First and foremost there is a greater range of activities that can be utilized in achieving compliance. Never has it been more important to audit and verify that your current procedures are in accordance with the regulatory expectations.

SOP GMP Compliance.

Why is there such a reluctance to follow written company procedures? Whatever the reason; it now ranks number one - as the subject matter in cGMP citations. This careless - don’t care – I’ve done it a hundred times – attitude, can no longer be accepted. Repeated internal audits Rule:

SOP Calibration Compliance.

Every sensor drifts – some more than others. That is why your predictive analysis must enable you to change or recalibrate an instrument before it goes out of specification. Past failures in this requirement; have caused calamitous troubles for cGMP companies. This SOP checks for ten calibration specific requirements that are absolutely essential.

SOP Spreadsheets Compliance.
Why are spreadsheets so problematic? Possibly because few people have been trained in the foibles of producing GMP compliant spreadsheets. Some spreadsheets are a disaster waiting to happen – recently we found ten variations of one spreadsheet which were in simultaneous use. Every spreadsheet creator must have a guidance document to work to.

SOP Quartet Package Offer

Four superb tried and tested Standard Operating Practice documents; almost for the price of one.

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