Quality Assurance - Pharma Egg

Jan272022 by KBS.No Comments

Annual Product Reviews SOP

Annual Product Reviews are created by all departments of the Pharmaceuticals Industry. Because Annual Product Reviews SOP reviews of products in all departments. PURPOSE To outline a procedure that Provides instructions for Annual Product Reviews (APRs) of all marketed products of Pharmaceuticals. Includes a collection of data, evaluation of data & review of data by Technical Team. SCOPE This SOP applies to all departments through which products are manufactured, packed, inspected and tested during a year i.e. from January - December time period. All batches finally closed in this duration are included in Annual Product Reviews. RESPONSIBILITY Quality Assurance Department. Enter the relevant data timely at respective...

Jan272022 by KBS.No Comments

cGMP Self Inspections SOP

Quality Assurance

The cGMP Self Inspections itself is performed in pharmaceutical production facilities in order to control the implementation of cGMP and the production process of the product. cGMP Self Inspections cGMP Self Inspections checklist plays an important role in self-control. cGMP Self Inspections is first and foremost a useful and powerful mechanism for identifying any deficiencies or errors operating in any system. That means one they should apply and monitor their own policies, if consistent, and take appropriate corrective action. It's a guaranteed way evaluate the entire operating system in all aspects to ensure and maintain product quality. cGMP Self Inspections is not limited to finding mistakes and foolishness, and infiltrators within the system, but also to find and plan ways to eff...

Jan272022 by KBS.No Comments

Control Of Non Conforming Products SOP 1

Quality Assurance

Control Of Non Conforming Products SOP is created for rejected material treatment, what should we do for rejected material in Pharmaceuticals. Control Of Non Conforming Products SOP In Pharmaceuticals Industry there is a proper way to dispose of every type of rejected material by a different way. In this SOP we also study this how pharmaceutical industries should dispose-off non-conforming products including Rejected materials according to guideline of WHO. 1. PURPOSE This SOP describes how to control, treat and dispose-off non-conforming products including Rejected materials. 2. SCOPE This SOP of Control Of Non-Conforming Products show controls all the steps taken in dealing with non-conforming products including reprocessing, rejected materials, Stability Study Batches and th...

Jan272022 by KBS.No Comments

Document and Data Control in Pharmaceuticals SOP

Quality Assurance

In SOPs of Document and Data Control, we come to know how Pharmaceuticals industries are putting SOPs and Form number, which are used in a different parts of industries. Document and Data Control Importance Document and Data Control have significant importance in Pharmaceuticals because every document in the pharmaceuticals industry need a number which refer to the documents, that's why in every form, SOPs, log book or any other documents you will see the Document and Data Control listed number. PURPOSE To ensure that all documents are controlled and distributed so that only current issues are in use by those Employees requiring them. Documents are properly reviewed and approved prior to issue and changes to documents are properly authorized. To ensure that all documents will go th...

Jan272022 by KBS.No Comments

Personnel Hygiene in Pharmaceuticals Industry SOPs

General Topics, Quality Assurance

Personnel Hygiene in Pharmaceuticals Industry SOPs is created to improve personnel hygiene of the employees that work in the Pharmaceuticals Industry. 1. PURPOSE To improve and maintain the conditions of personnel hygiene of the employees according to regulatory authority requirements and international standards. 2. SCOPE This SOP applies to all employees entering the manufacturing and warehouse areas of Pharmaceuticals. 3. RESPONSIBILITY 3.1 HR Manager is responsible for initial and ongoing health examination of the employees. 3.2 Administration staff monitors personnel hygiene standards of all employees entering in process area and ensures that overall working environment of the company shall be as per SOP. 3.3 Department head / Section in-charge ensures observance of per...

Jan222022 by KBS.No Comments

SOP on SOP in Pharmaceuticals

Quality Assurance

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...