Quality Assurance

In the post so deeply describe the Handling of Retained Samples & Batch History Records which help Pharmaceuticals in maintaining records. Objective To describe the Handling of Retained Samples & Batch History Recordsarticle for receive, review, retention & issuance of Batch History & Retained Sample in compliance of cGMP. Scope This procedure is applicable at Pharma. Responsibilities Manager QC/QA Officer Quality Assurance / Quality Management & Quality Control Inspector Quality Assurance & Lab attendant Definitions Batch records All documents are related to making bulk products or finished products. They provide a history of each batch of product and of all circumstances pertinent to the quality of the final product. Authorized Person The pe...

To describe the procedure for sampling of different materials in pharma as per quality control requirements. In this blogpost we will study how to sampling of Raw Material, Packing Material etc. Sampling of Different Materials in Pharma Scope: This procedure is to be used as basic guideline for different sampling procedures to ensure the safe and representative sampling of the materials required by quality control for different purposes. Responsibility: QA Officer/ Senior QA Officer Procedure: Raw Materials General Receive the Raw material Goods Receiving Note (GRN) from Raw Material Warehouse (RMWH) upon arrival of raw materials. Eateries are made in inventory system through by the store pharmacist. Then after receiving the Certificate of Analysis and other necessary document i...

During manufacturing process Quality Assurance department Sampling on different stages and if result does not math they again sapling. In this blog post we study how In-Process Sampling and Re-Sampling in Pharma done by Q.A Department. 1. Purpose: 1.1. To establish a procedure for the In-process sampling during the manufacturing of all products. 2. Scope: 2.1. It is applicable to all the products being manufactured ____________ Pharmaceuticals. 3. Responsibilities: 3.1. QC Officer 3.2. Production Pharmacist 3.3. Q.A Officer 3.4. Lab Attendant 4. Procedure: Sampling procedure and sample size is mentioned below for each process/stage: 4.1. GENERAL: 4.1.1. Quality Assurance Manager receives the request for analysis (F-04-05) from Production Department. 4.1.2. QA Officer/Lab ...

Before Manufacturing any product in the Pharmaceuticals industry, we have to ensure that Line Clearance in Pharma product manufacturing is working well. 1. Destination:   1.1. To establish a line cleaning procedure before each stage of manufacturing products. 2. Scope: 2.1. This procedure applies to all stages of a product from expenditure of raw materials to the final packaging of products produced in bio-mark pharmacy. 3. Responsibilities: 3.1. Supervisor section 3.2. QA Manager. 3.3. QA Officer. 4. Procedure: 4.1. QA accepts "verbal intimacy for line clearance" from the raw material store for expenditure of raw materials, making it in BMR and removing raw materials according to SOP. 4.2. QA accepts "verbal intimacy for line cleaning" from the production department bef...