PrincipleSampling is an important operation in which only a small fraction of a batch is taken. Valid conclusions on the whole cannot be based on tests which have been carried out on non representative samples. Correct sampling is thus an essential part of a system of Quality Assurance.NoteSampling is dealt with in Chapter 6 of …
Shilpa Medicare Limited FDA Warning Letter 2020 Delivery Method:VIA UPSProduct:Drugs Recipient:Mr. Vishnukant Chaturbhuj BhutadaManaging DirectorShilpa Medicare Limited #12-6-214/A1 Hyderabad RoadRaichur 584135 KarnatakaIndiaIssuing Office:Center for Drug Evaluation and Research | CDER United States Warning Letter 320-21-01 October 9, 2020 Dear Mr. Bhutada: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility at Shilpa Medicare Limited, …
A cleaning validation protocol format shall be developed for the ‘worst case’ product selected for cleaning validation programme. Following information (but not limited to) the following included in the cleaning validation protocol. Numbering of protocol shall done through of respective SOP of Cleaning Validation Protocol Numbering. Cleaning Validation Protocol Format – Objective: A brief description …
The manufacturer or supplier who is supplying the material in routine and registered for the supply of specific material after the approval process considered as an approved vendor. Vendor management consists of the Identification, Qualification, Requalification, management of changes at the vendor site, Vendor Audit, Technical Agreement, Deregistration Process, etc. Vendor Management PURPOSE: The …
Standard Operating Procedure (SOP) for Review of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) in the pharmaceutical manufacturing plant. A detailed checklist for review of BMR and BPR for Draft Copy as well as Filled Copy of Batch Manufacturing/Packing Records. Procedure for BMR & BPR Review 1.0 PURPOSE: The purpose of …
Standard Operating Procedure (SOP) for Handling Power Failure situations in different areas like Production, Quality Control, Microbiology, Utility, Stores, etc at the pharmaceutical drug manufacturing plant. Procedure for Handling of Power Failure in Pharma 1.0 Purpose: To lay down a procedure for handling power failure situations. 2.0 Scope:This procedure is applicable to handling power failure …
Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply chain/distributors or C&F warehouses. Procedure for Finished Product Batch Release1.0 PURPOSE: To lay down the procedure for approval and release of the finished product batch. 2.0 SCOPE: This Standard Operating Procedure is applicable for all …
At EU-level there are not fixed rules about how risk assessments should be undertaken (you should check the specific legislation relating to risk assessment in your country). However, there are two principles which should always be borne in mind when approaching a risk assessment: to structure the assessment to ensure that all relevant hazards and …
European Guidance On:
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CAPA (Corrective Action & Preventive Action) is an area that we talk about often, mainly because it’s still such a big issue for companies. This time, we’re looking at a step-by-step process that, if done well, should help any company to get a good result from their CAPA process. A STEP-BY-STEP CAPA PROCESSThe key thing …
