When it comes to reviewing documents such as batch records, qualifications, validations, and other important documents, there are certain items that should be reviewed carefully. The reviewing of documents is a very important task within a company. Let’s take a closer look into the components of reviewing documents.
The reviewing of documents is a very important task within a company. The documents become a permanent record for the company, and you want them to be as perfect as you can get them. Let say the manufacturing team just completed a batch record and now needs to be reviewed. A member of the quality assurance department now must review the record.
Reviewing documents is a crucial part of a company’s success. Several issues can arise if a document is not reviewed properly, which can cause trouble down the line in an audit. There could be signatures missing, wrong calculations, equipment used that is out of calibration, wrong raw material numbers, steps may have been missed, or personnel training may not be up to date. Any of these could be cause for concern to an auditor. Therefore, document reviews are so important to catch the mistakes and fixed them before an inspection.
The following should be reviewed for batch records, qualifications, validations, calibration certificates, certificate of analysis, and any other documents.
- Training– Anyone performing a task must be adequately trained on the task at hand. Training records must be reviewed for each person performing any actions. Training records will be needed for this review.
- Equipment– Any piece of equipment used must be numbered and within calibration/ qualification. Equipment logs will need to be accessed to review this information on the equipment.
- Raw Material– Any raw material used must have a released sticker and expiration date. Raw material logs with this information must be handy to review this information.
- Calculations– All calculations performed in the document must be re-calculated for correctness.
- Missing Steps– Make sure that all steps are completed in order with signatures and the correct dates.
- Other– Make sure that entries are within specification, units are correct, dates and times are entered correctly, and make sure signatures and initials are where they are supposed to be.
When it comes to reviewing documents, you want to go through them with a fine comb. Make sure all errors are found and corrected before signing off on the document. Many companies have a member of their department review the document and then have quality assurance review it as a double-check. The more eyes on a document, the more likely you will find as many errors as possible.
Document review is a very important part of how well a company will do. When an auditor comes for an inspection, the documents are what they will ask to look at first. If the documents and records are in order, it sets a good tone for the rest of the inspection and hopefully avoid 483s from the FDA.
PSC Biotech can provide experts in technical writing, as well as provide audit support and project management. We offer a variety of services thanks to our vast network of expert consultants. Contact us now to find out more!
PSC Software Solutions
PSC Biotech Services provide fast, budget-friendly, high-level expertise.
Share, Engage, Stay Current
Regulatory Strategy Development for Life Sciences: Best Practices
Regulatory Affairs and Winning Regulatory Strategy Regulatory strategy development is critical for life sciences companies seeking to bring new drugs, medical devices, and other products to market. Developing an effective regulatory strategy can help companies...
The Secret to Writing Successful Grant Proposals
Grant writing aims to prepare and submit a proposal to request funding from a grant-making organization, such as a government agency, private foundation, or corporation. Grant writing involves researching potential funders, understanding their priorities and...
Benefit- Risk Assessment for Regulatory process
Benefit-risk assessment is critical to the regulatory review process for life science companies and healthcare products, including drugs, biologics, and medical devices, before it is approved for use by regulatory agencies such as the Food and Drug Administration...