Quality Assurance - Pharma Egg

Jan222022 by KBS.No Comments

SOP on SOP in Pharmaceuticals

SOP on SOP in Pharmaceuticals for Formatting, Approval, Distribution & Retrival. This format is apply on all the Department SOP. SOP on SOP in Pharmaceuticals Sop on Sop is created by Quality Assurance Manager to improve the Quality of formating on Standard Operating Procedure and create a separate look in SOP. OBJECTIVE 1.1. The objective of this procedure is to lay down the procedure for the Preparation, Review, and Approval. Implementation, Distribution Retrieval and Control of Sop on Sop (Standard Operating Procedures). SCOPE 2.1. The procedure applies to all departments of ____Pharmaceuticals for the preparation of Sop on Sop and Forms. RESPONSIBILITIES 3.1. It is the responsibility of all ____Pharmaceuticals employees to follow this SOP as it is in written. 3.2. It i...

Jan222022 by KBS.No Comments

Pharmaceuticals Product Recall SOP

Quality Assurance

Pharmaceutical Product recall is defined as the removal of a product sold by the Company due to design or manufacturing defects that could compromise efficiency and safety. Product Recall Product purity or by government order. Withdrawal of a product from the market may begin if the product is suspected to be defective or is found to be defective on the basis of a market power study. complaints, assessment of the likelihood of danger or as prescribed by the FDA or the Authority the health / regulatory authorities (RAs) of the country where the product is sold. OBJECTIVE 1.1 The Objective of this SOP is to describe procedure for the product recall, responsibilities, actions its evaluation and to provide guidance on: 1.1.1 Circumstances under which a recall of product(s) is warrant...

Jan222022 by KBS.No Comments

Internal Audit in Pharmaceutical Industry SOP

Quality Assurance

Internal Audit in Pharmaceutical Industry is important to functional Quality Standards in every pharmaceutical production industry. When planning Internal Audit in Pharmaceutical Industry, the primary goal should be to keep in mind information collection and identification of all problem areas. Internal Audit in Pharmaceutical Industry SOP Internal Audit in Pharmaceutical Industry SOP is based upon standard FDA guidelines which are applied on every pharmaceuticals manufacturing industry. PURPOSE 1.1. To describe procedure for planning, execution, reporting and follow up of cGMP Internal Audit in Pharmaceutical Industry. SCOPE 2.1. This c.GMP audit procedure is applicable to all departments involved in Manufacturing, testing and storage of products. RESPONSIBILITIES 3.1. It is...

Jan222022 by KBS.No Comments

Inprocess Checking During Manufacturing SOPs

Quality Assurance

In post detail are given of Inprocess Checking During Manufacturing to maintained quality of all pharmaceuticals products. Inprocess Checking During Manufacturing SOPs To maintain and improve the quality of drug we need to Inprocess Checking During Manufacturing as per guidelines so that the potency of drugs increases. Purpose: This SOP "Inprocess Checking During Manufacturing" is designed to check the good manufacturing practices and Quality of all products during manufacturing (CGMP). Scope: This SOP "Inprocess Checking During Manufacturing" covers the all the Inprocess Checking During Manufacturing of solid Dosage forms that is Tablet and Capsule. Responsibilities: a. It is the responsibility of all Production Pharmacists, Production Staff and Q.A officers to follow this SOP dur...

Jan202022 by KBS.No Comments

Temperature and Humidity Control in Pharma

Quality Assurance

In the Pharmaceuticals manufacturing and storage areas Temperature and Humidity Control in Pharma is very import. There are so many precaution are necessary for Temperature and Humidity Control in Pharma . INTRODUCTION Temperature and Humidity Control in Pharma is defined as the extent to which a product retain within its specified limits and throughout its period of storage and use i.e. (its shelf life) the same properties and characteristics that it possessed at the time of its manufacturing. So, the substances and finished products described in the pharmacopoeia should be stored under conditions that prevent contamination and as for as possible. Precautions that should be taken in relation to the effects of the atmosphere, moisture, heat and light are indicated where appropriate in mo...

Jan192022 by KBS.9 Comments

Handling of Retained Samples & Batch History Records

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...

Jan192022 by KBS.No Comments

Sampling of Different Materials in Pharma SOPs 1

Quality Assurance

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...

Jan172022 by KBS.1 Comment

In-Process Sampling and Re-Sampling in Pharma

Quality Assurance

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 ...

Jan172022 by KBS.No Comments

Line Clearance in Pharma SOPs

Quality Assurance

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...