The purpose of Blister Machine Operation Qualification is to establish documentary evidence to ensure that the installed Blister pack machine will operate reproducibly and consistently within its full dynamic range of operation according to the manufacturer’s specifications and to demonstrate that the control panel and other manual operation of the Blister packing machine provide the … Read more
Learn about Standard Operating Procedure on FBD Bag including their, Purpose, Scope, responsibility, Procedure for Indenting, Receiving, cleaning, storage, Issuance and Coding of FBD Bag. 1.0 Purpose: To lay down Standard Operating Procedure for Indenting, Receiving, Issuance, Coding, Usage, Cleaning, and Destruction of Fluidized-bed Dryer Bag.2.0 Scope: This SOP applies to all the FBD Bags used in the Tablet … Read more
A Drug master file is a submission form, that is required to submit to the Food and Drug Administration (FDA). A US DMF (Drug Master File) is a document that is submitted to regulatory agencies to provide confidential, detailed information about a drug API, drug product, or excipient. It is used to support the approval … Read more
In this discussion, we will delve into two very important terms associated with drug products: drug product assay and drug product potency. The aim is to clear vision on their interrelation, differences, and significance, as guided by the ICH guideline Q2 R2, which focuses on analytical method validation. Drug Product Assay Definition and Purpose A … Read more
The instrument being discussed in this context is known as a Flow Injection Analyzer (FIA). Its primary function is to automate several processes typically associated with conventional wet chemistry procedures. Specifically, the Flow Injection Analysis is designed to perform tasks such as automatically picking up samples, mixing them with the required reagents, and subsequently detecting … Read more
In pharmaceutical manufacturing, coating tablets requires careful attention to detail to prevent issues like tablet twinning. Twinning is common with capsule-shaped tablets, where two tablets stick together, resembling conjoined twins. This discussion focuses on tablet coating specialists and quality control experts, explaining the causes and solutions for tablet twinning. Tablet Twining: Understanding the Defect When … Read more
Learn about the Installation Qualification Protocol for Blister Packing Machine along with Annexures. The purpose of this protocol is to establish documentary evidence to ensure that the Blister packing machine received matches the Design specification and also to ensure that it is properly and safely installed. Serial No. Item Description 1.0 PROTOCOL APPROVAL 2.0 OVERVIEW: 2.1 … Read more
There are many pharmaceutical manufacturing companies in India, but only a few are leading in the manufacturing and marketing of pharmaceutical products. We have prepared a list of India’s top 10 pharmaceutical manufacturing companies in 2024 according to recent data obtained from different sources. The list is based on their current growth with their regulatory approval and … Read more
Qualification refers to activities undertaken to demonstrate that utility and equipment are suitable for their intended use and performing properly. Qualification Definition: It is the action of providing and documenting that equipment or ancillary systems are properly installed, work correctly, and accurately leading to the expected results. Qualification is a part of validation but individual … Read more
Differential pressure in pharmaceuticals helps to prevent contamination and cross-contamination. A Magnehelic gauge device is used to measure the pressure difference between the two adjacent sections. The gauge has two inlets point for the pressure that is connected to the area being monitored. Differential pressure is the pressure that differentiates between the pressure of the atmosphere of … Read more
A Dissolution Test is used for in vitro Testing of the Tablets and Capsules. Dissolution provides the product Release info to know the drug delivery. Dissolution apparatus are used throughout the product development life cycle, from Product release to stability testing and study of the product data from product to product. Then after passing or approval from the … Read more
The purpose of the Blender Installation Qualification protocol is to establish documentary evidence to ensure that the Pillar Type Blender system received matches the Design specification and also to ensure that it is properly and safely installed. The equipment shall be used for blending different granules/powders to be used in the formulation. The equipment shall … Read more
The aim of developing the Operational Qualification Protocol of Pillar Type Blender is to collect enough details about the Pillar Type Blender. We want to set out the conditions needed for this machine and ensure that everything it does matches what it was designed for. We also want to ensure that the limits mentioned in … Read more
The objective of developing and executing the Blender Performance Qualification protocol is to document the verification of all aspects of the equipment that can affect product quality. To make an impact assessment of the critical components of the equipment on the material to establish, check, and document the performance of equipment in the established/predetermined operating … Read more
The purpose of the Auto Coater Operational Qualification protocol is to establish the documentary evidence to ensure that the installed Auto Coater shall operate reproducibly and consistently within its full dynamic range of operation according to the manufacturer’s specifications. SERIAL NO. ITEM DESCRIPTION 1.0 PROTOCOL APPROVAL 2.0 OVERVIEW: 2.1 Objective 2.2 Purpose 2.3 Scope 2.4 … Read more
The purpose of the Auto Coater Performance Qualification protocol is to verify that the equipment produces the desired output. Once the equipment is installed and Operational qualification is done, we shall plan to check its performance. The equipment’s working capacity is challenged by charging the equipment with the maximum and minimum capacity of the equipment. … Read more