Category: Uncategorized

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? →

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 Processing, … 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) →

Handling of Out of Calibration in Laboratory


1.0 OBJECTIVE : To lay down a procedure for investigating and handling of Out of Calibration (OOC) of measuring device/Instruments. 2.0 SCOPE : This SOP is applicable to Out of Calibration of measuring device or instruments which are used for testing of Raw material, Packaging material, Finished Product and Stability samples in Quality Control Department. … Continue reading Handling of Out of Calibration in Laboratory →

Temperature Mapping in Pharmaceuticals


1.0 OBJECTIVE : To describe a procedure for Temperature Mapping. 2.0 SCOPE : This SOP is applicable for the temperature mapping of storage, testing/incubation, chamber or any closed area. 3.0 RESPONSIBILITY : Concerned Departmental Head Quality Assurance Head 4.0 ACCOUNTABILITY: Quality Assurance Head 5.0 PROCEDURE : 5.1 A validation activity that centers on temperature and for relative … Continue reading Temperature Mapping in Pharmaceuticals →