1.Objective To lay down procedure for preparation, review, approval, issuance & retrieval of Standard Operating Procedure. (SOP) 2.Scope This procedure is applicable to preparation of SOP for all the cGMP activities. 3.Responsibilities User Dept. QA Dept. 4.Procedure: The procedure is described further into sub parts. i.e. Preparation, Review , Approval, Distribution, Retrieval, & retention. Structurally … Continue reading SOP of SOP in Pharmaceutical Industry (How to Prepare SOP)
Deviation Flow Chart
Difference between Dynamic and Static Pass box
In pharmaceutical manufacturing industries, pass boxes are normally used to transfer a particular material between two areas generally of different cleanliness levels. The boxes can be said to transfer the materials from a high level of cleanliness to a lower level of cleanliness or vice-versa. The pass boxes while transferring the material, help to prevent … Continue reading Difference between Dynamic and Static Pass box
Flow Chart of Change Control
How to respond to 483 observation & Warning Letters?
As a recipient of a response warning letter, it is important to follow the basic steps outlined below to ensure a timely and effective response. 1) Acknowledge receipt of the letter through certified mail, informing the FDA that we intend to respond within 15 business days. This initial correspondence should be brief, simply and serve … Continue reading How to respond to 483 observation & Warning Letters?
Stability Study Flow Diagram
Fluid Bed Dryer (FBD)Interview Questions and Answers
1. What is Fluid Bed Dryer (FBD) : Fluid bed dryer which is used in pharmaceutical industries to dry the wet mass of granules or to remove the moisture content from the wet granules without changing their physical attributes during the process of wet granulation. FBD is used in different industries like Pharmaceutical, Chemical, Food … Continue reading Fluid Bed Dryer (FBD)Interview Questions and Answers
Common terms used in USFDA Inspections
Types of USFDA inspections. Pre-approval/Application-based inspection = conducted before the USFDA approves a new drug, biologic, or medical device for marketing in the US. Routine/GMP/Surveillance/Post marketing inspection = conducted periodically to ensure that the manufacturing facilities and processes continue to comply with cGMP regulations. Compliance follow-up = conducted to verify that a facility has taken … Continue reading Common terms used in USFDA Inspections
Specific Requirements for Manufacturing of Oral Solid Dosage Forms (Tablets and Capsules)
1. General:- 1.1. The processing of dry materials and products creates problems of dust control and cross-contamination. Special attention is, therefore, needed in the design, maintenance and use of premises and equipment in order to overcome these problems. Wherever required, enclosed dust control manufacturing systems shall be employed. 1.2. Suitable environmental conditions for the products … Continue reading Specific Requirements for Manufacturing of Oral Solid Dosage Forms (Tablets and Capsules)
Wash in Place (WIP)and Clean In Place (CIP)
Washing is a major part of various activities performed in different industries like the dairy and pharmaceuticals. As we know in the pharmaceutical industry we have to perform cleaning activities all the time whenever we have a change of product or depending on the requirement according to standard cleaning procedures. WIP or wash in place … Continue reading Wash in Place (WIP)and Clean In Place (CIP)
Pharmaceutical Updates 