I am looking for the Batch Manufacturing and Packing record format, which is most acceptable as per GMP. Please share if you have the same.
Thanks & Regards
Babikir
Dear Babikir,
As a Pharmaceutical professional, you should know that BMR & BPR are the confidential documents and exclusive property of the organization. So, we are unable to help you. However, these documents vary form company to company, product to product and formulation to formulation. If you mention your exact requirement (ex. API / orals / parentarals / PFS etc), I can provide you the outline (table of contents) and you can develop your documents
Regards
Veerraju
At times formats does not work. The reason is one must know, understand and execute such an important document as per compliance. One must write their own BMR and or BPR.
-You formualtion activities
-Your dispensing activities
-Your primary compoenent preperation activities
-Your control and sterilization procedures
-Your inprocess controls
-Your line clearences
-Your equipment status and operational status
-Your personnel and their signatory authority
-Your filling and Packing procedures
-Your utility requirements and minitoring specific controls of Pressure,temperature, Humidity, Air velocities etc etc
-Your reconcilliation methods
-Transfer of finished goods to ware house
-Your batch nonconformaces
-Your release and GMP certifications.
Its a complex affair and not a file or protocol to copy. BMR and BPR is the document that represent FACE OF QUALITY of your company.
Never copy it from others.
You should help yourself.
You should first make a flow chart of all activities and then sit with your QA and QC putting all yourt controls in that.
Then formulate.
Its a total team affort to Write, review, correct and approve and release such a quality document.
Everything must be traceable and must be in order of compliance.
Descrapancies will pave way for product recalls.
Group effort is a pride and compliance activity.
There is no shame in asking others for your own organization.
One blunder in that will ruin your company’s reputation and your career too.
Regards