Points which are ignored during preparation of Annual product quality reveiw APQR.
Annual product quality review APQR is very important document it’s not mandatory document yet it is demanded by almost all regulatory agencies, as a part of comiance to Guidelines issued by WHO and USFDA.
The purpose of preparing an annual product quality review is to have a clear picture about the product’s quality irrespective of whether the product has failed or the product complied with all the standards with no any concerns. The APQR report provides clear judgment about the quality of the product, if the product batches manufactured were of good quality or had any problems?
Which point are covered in the annual product quality review report APQR is prepared?
For making APQR of one product is considered at a time.
People will tell you to write RM PM, but what to write in the RM PM? As given below, other blogs tend to provide wrong information.
All the tests which are indicative of the quality of the product are written beside the batch number in table form, for example, PH, assay, net fill value, primary packaging material manufacturer vendor, Assay of all API used in the batch to write beside the batch number, overages added. Packed quantity, and sample quantity for testing or retention sample.
Why is the API considered in APQR? suppose if any batch shows an out of trend result during storage, it will become an assay to identify the root cause based on the ready comparative data of API their assay and make, it will be easy to identify the problem associated with a particular manufacturer of API.
PH is a very important quality attribute for stability and efficacy of a product, similar to assay of API Final product PH too will help to identify any quality defect.
Primary packaging materials are very important, with respect to sterility and stability of the product concerned, making ready data in an APQR makes it easy to have a review at all the quality attributes of the product.
What is important to write in APQR:
1)Final packed Qty, if any batch yield is going out of trend a valid explanation reconciliation is required to be provided.
2)Out of specification OOS Out of trend Batches: Details of the Investigation report easily retrievable are written.
3)Any changes done during the manufacturing of the batch, the change control details.
4)Deviations, incidents during the manufacturing and packing of a batch.
5) Corrective and preventive actions implemented for the batch, to be written CAPA number in the column.
6) Validation batches taken to highlight as validation batches.
7)Most important part of the APQR is representation of data as charts, graphs, pie graphs, Bar Graph etc., a peak away from the trend line is indicative of deviation from the trend.
Annual quality product review is asked by US FDA, WHO, CDISCO, EU, MHRA during the inspection of a facility.