Isolator in pharmaceuticals has a significant place in the production of sterile products because of their decontaminated environment. They meet Grade A conditions and provide continuous isolation from its interior to the external environment. The Evolution of Aseptic Processing If we talk about their Journey, aseptic processing has been quite interesting, taking us from traditional … Read more
Learn About SOP of SOP (How to Write SOP by implementing Different Fonts, Size, Title, Logo, Stamps, Formats, BMR/ BPR, Spec/STP, protocols, Worksheets, Reports, and Logbooks, and Annexures as per the Pharmaceutical Guidelines). 1.0 OBJECTIVE: 1.1 To lay down the procedure for the preparation of SOP (SOP on SOP), Format, Numbering, Review, Approval, Implementation, Distribution, … Read more
The purpose of the Installation Qualification Protocol for Automatic Capsule Filling Machine is to establish documentary evidence to ensure that the Automatic capsule filling machine system 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 Objective 2.2 Purpose … Read more
Performance Qualification Protocol for Blister Machine is designed to provide documented evidence that the functions of the equipment, which affect the product quality, equipment integrity, and safety of operating and maintenance personnel are considered. SERIAL NO. ITEM DESCRIPTION 1.0 PROTOCOL APPROVAL 2.0 OVERVIEW: 2.1 Objective 2.2 Purpose 2.3 Scope 2.4 Responsibility 2.5 Execution Team 3.0 … Read more
Learn About Standard Operating Procedure for Handling of Deviations in pharmaceuticals | Types of deviations | Deviation Flow chart | Devations Guidelines | Deviation Numbering | Deviation management. 1.0 OBJECTIVE: 1.1 To lay down that deviations from manufacturing instructions and quality-related procedures are recorded, investigated, and evaluated for their impact on product quality in a … Read more
Learn About SOP on Transfer and Receipt of bulk (Active Raw Materials) from the Warehouse to the Production area. 1.0 Purpose: To describe the procedure for transfer and receipt of bulk (Active Raw material) from the warehouse to the production area (Vaccine Formulation). 2.0 Applicable: This Standard Operating Procedure applies to the transfer … Read more
Learn About the Procedure for Thawing of Solution and Active Raw Material stored at or below -20 degrees C. 1.0 Purpose: To lay down the procedure for thawing of active raw material & solutions that are stored at or below -20 degrees C. 2.0 Applicable to: This Standard Operating Procedure is applicable for thawing of … Read more
Madhya Pradesh’s pharmaceutical industry presents a golden opportunity for investors. This place is known for its good strategic location. Below is detailed information about MP Pharma companies, including their key facts and regional impact. So Let’s check out the full details about Pharma Companies in Madhya Pradesh including their reaching address. MP Pharma Industry Overview … Read more
Jammu Kashmir, a top tourism spot in India, known for its stunning beauty, is home to about 13.6 million people. If you’re in Jammu Kashmir and looking to kickstart something new, why not consider setting up your business plan? Lots of industries are already taking different types of perk benefits to expand their business. Thinking … Read more
Faridabad is a Booming Hub for Industrial Development Long before Gurgaon made its mark, Faridabad led the charge as the preferred location for industrial development in Haryana. Its proximity to Delhi and strategic positioning along the Delhi Mathura Road have made it an attractive option for businesses. Today, lots of pharmaceutical companies in Faridabad are … Read more
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