Standard Operating Procedure (SOP) for Operation and Cleaning of Metal Detector and Combo Metal Detector cum Deduster used during the manufacturing of drug products in pharmaceuticals. SOP for Metal Detector / Deduster 1.0 PURPOSE: The purpose of this SOP is to describe the cleaning and operation of metal detector and digital combo metal detector cum …
Technology transfer/product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the first batch, received from the parent location or FDD of a new or existing product from a particular site with manufacturing, packaging and analytical details. SOP on Technology Transfer of Drug Product 1.0 PURPOSE: …
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 …
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:
HOW TO CARRY OUT A RISK ASSESSMENT Read More »
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 …
Principle. All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and the corrective action should be taken. A person responsible for handling the complaints and deciding the measures to be taken should be designated, together with sufficient supporting staff to assist him or her. If this person …
The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals. Objective : The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for defining job responsibilities of individuals. Scope : This SOP is applicable to all responsible persons of pharmaceutical Industry …
Validation Master Plan A manufacturer should have a VMP which reflects the key elements of validation. It should be concise and clear and contain at least the following: ‒title page and authorization (approval signatures and dates); ‒table of contents; ‒abbreviations and glossary; ‒validation policy; ‒philosophy, intention and approach to validation; ‒roles and responsibilities of relevant …
COMPLAINTS AND RECALLS All quality related complaints, whether received orally or in writing, should be recorded and investigated according to a written procedure. Complaint records should include: − Name and address of complainant; − Name (and, where appropriate, title) and phone number of person submitting the complaint; − Complaint nature (including name and batch number …
Complaints And Recalls Handling In API Manufacturing Unit- Pharma Read More »
