If you’ve approved Googling the FDA requirements for Acceptable Affidavit Practices (GDP), you’ll acquisition that they don’t abide because it’s an accepted convenance and not a Code of Federal Regulations (CFR) requirement. At best, you can acquisition a few references in the Medical Accessory Quality Systems chiral (Section 9) and ICH Q7A (Section IV-A).
Typically, if anyone uses the appellation acceptable affidavit practices, it’s in advertence to entering abstracts or authoritative corrections to a controlled record. However, there are added aspects of acceptable affidavit practices that cover the formatting of controlled records, signatures and approvals, and certificate hierarchy. This commodity focuses on how to access abstracts or accomplish corrections to a controlled record.
The purpose of acceptable affidavit practices is to acutely certificate what accomplishments took abode in the development or accomplish of a drug, biologics, vaccine, medical device, etc. so that anyone, including an auditor, has authentic affirmation that you did absolutely what you said you did. Keep in apperception that a controlled almanac is advised a acknowledged document, so the abstracts needs to be acutely authentic for acknowledged and canning purposes. In the Biotech Industry we administer acceptable affidavit practices with every almanac or certificate and crave a analysis of the attempt during your new appoint training. There’s a adage that’s accomplished into you from day one ‘If you didn’t certificate it, again it didn’t happen’.
Entering Abstracts Into A Controlled Record
Apply the afterward practices if you’re entering abstracts into a controlled record:
Use enduring (water-resistant) dejected or atramentous ink so that it doesn’t achromatize over time or blemish if it gets wet. No pencils or felt-tipped markers allowed
Enter abstracts anon in the controlled almanac and never on a section of atom cardboard in the interim
NEVER aback date!
Make abiding the entries are authentic and bright so that anyone can accept your entries
Document dates in a connected architecture as defined in your Standard Operating Procedure
Draw a askew band through any bare fields or abandoned spaces at the basal of a page and cover ‘N/A’ forth with your brand and date. Bare fields can be interpreted as missing abstracts and abandoned spaces at the basal of a page (e.g. lab notebooks) can accord anyone the befalling to add abstracts after your ability or consent.
Number anniversary page in a controlled anthology chronologically. This verifies that no pages are missing
Paginate accessories (e.g. page 1 of 10)
For apparatus printouts, attach with bright adhering band and cover your brand and date area the printout is absorbed so that allotment of your initials/date will be on the adapter and allotment will be on the notebook
When entering repetitive data, do not use akin marks
Making Corrections To A Controlled Record
Apply the afterward practices if authoritative corrections to a controlled record:
Draw a individual band through the advice that needs to be corrected, authoritative abiding not to author out the aboriginal data, use white out or address over abstracts (e.g. about-face a aught into the amount nine) because it hides the aboriginal data
Briefly accompaniment what’s amiss with the advice (e.g. amiss date) and certificate the actual information
Initial and date if the corrections were made
NEVER aback date. This is so important that it’s mentioned twice!
Changes or additions to annal column approval crave the certificate go through the approval action again
Although acceptable affidavit practices are about begin in FDA adapted industries, it’s absolutely benign for any industry to accept these practices.