Photostability Testing of New Drug Substances and Products
Photostability Testing of New Drug Substances and Products in pharmaceutical industry
CGMP
33 articles tagged “CGMP”
Code of Federal Regulations, CFR
The list of titles of the Code of Federal Regulations The 21 CFR is the Title 21 for Food and Drugs
Changes in 21 CFR Part 11 Subpart C, Electronic Signatures
Update on recent changes in 21 CFR (Code of Federal Regulations) On 02nd March 2023; The text of § 11.100 General requirements of Subpart C Electronic…
Multiple Endpoints in Clinical Trials Guidance for Industry
GUIDANCE DOCUMENT Multiple Endpoints in Clinical Trials Guidance for Industry OCTOBER 2022 Docket Number: FDA-2016-D-4460 Issued by: Center for Biologics…
Size, Shape, and other physical Attributes of Generic Tablets and capsules
US FDA has revised the guideline for Size, Shape, and other physical Attributes of Generic Tablets and capsules. USFDA Guidelines
Purified Water [PW]
PW is used as an excipient in the production of nonparenteral preparations & in other pharma applications, such as cleaning of equipment.
WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
Installation Qualification [IQ]
The performance of tests to ensure that the system etc. used in a manufacturing process are appropriately selected and correctly installed.
Factory Acceptance Test (FAT) in Pharma: Checklist & Scope
Factory Acceptance Test (FAT) for Equipment, Utility, System, Facility in the pharmaceutical industry.
What is Difference between Quality Control and Quality Assurance?
What is Difference between Quality Control and Quality Assurance?
Design Qualification [DQ]
Design Qualification [DQ] Documented evidence that, for example, the premises, supporting systems, utilities or equipment have been designed for their…
User Requirement Specification (URS) in Pharma + Template
User Requirements Specification (URS) is An authorized document that defines the User requirement in Pharmaceutical Industry
Basic Flow of Qualification [Equipment, Utility, System, Facility] in Pharmaceutical Industry
Basic Flow of Qualification [Equipment, Utility, System, Facility], URS, DQ, FAT, SAT, IQ, OQ, PQ
VALIDATION MASTER PLAN (VMP)
VALIDATION MASTER PLAN 1. Principle 1.1. Validation in general requires a meticulous preparation and careful planning of the various steps in the process.
Conductivity Meter Calibration: Procedure & Acceptance
Conductivity: It is the ability of a solution to conduct electricity and the electricity is conducted in solution by ions present.
SOPs in Pharmaceuticals: Format, Structure & Writing Guide
Standard operating procedures (SOPs) are the detailed written instructions that specify how a test or administrative procedure is to be performed, or how a piece of equipment is operated, maintained and calibrated. SOPs describe the \"standard\" approved procedures that are routinely carried out in a GMP facility. They indicate exactly how things are done and are kept current by review and approved revision on a predetermined schedule
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products
Update on New Guideline; by USFDA Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format…
Good Chromatography Practices
Good Chromatography Practices for the pharmaceutical industry
Personal Hygiene in Pharmaceuticals: GMP Requirements
Personal hygiene requirements in the pharmaceutical industry
Films PHARMACEUTICAL DOSAGE FORMS
USP-43 〈1151〉 Films PHARMACEUTICAL DOSAGE FORMS
Capsules PHARMACEUTICAL DOSAGE FORMS
Capsules PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43, Chapter <1151>
Aerosol Dosage Forms: Types, Formulation & Examples
Aerosols PHARMACEUTICAL DOSAGE FORMS, United State Pharmacopoeia USP-43
Pharmaceutical Dosage Forms: Complete Classification List
〈1151〉 PHARMACEUTICAL DOSAGE FORMS This article is based on the requirement of the United State Pharmacopoeia.
Good manufacturing practices for medical gases
Working document QAS/21.875, February 2021. World Health Organization (WHO) has published the DRAFT WORKING DOCUMENT FOR COMMENTS.
Parenteral Dosage Forms: Types, Requirements & Examples
INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS This article is based on the requirement of the United State Pharmacopoeia…
INSPECTION OF UTILITIES
Co-operation Scheme (PIC/S) has revised the guidance document for INSPECTION OF UTILITIES on 19 January 2021
GMP INSPECTION RELATED TO PACKAGING
Co-operation Scheme (PIC/S) has revised the guidance document for GMP INSPECTION RELATED TO PAC on 19 January 2021
QRM Implementation: PIC/S Aide-Mémoire & Assessment Guide
Pharmaceutical Inspection Co-operation Scheme (PIC/S) Leading the international development, implementation, and maintenance of harmonized GMP standards…
Site Master File (SMF): WHO Format, Contents & Example
In this article, we will discuss a practical approach to prepare the Site Master File (SMF) for the Pharmaceutical Industry. We have to understand that The SMF is the document which explains your organization; it creates the image of the organization, So it should be self-explanatory as in most of the case you are not present to explain the SMF.Do you believe that the SMF is creating the first impression of your organization before visiting your Site…After discussing with various regulatory auth
Pharmaceutical Documentation: Hierarchy, Types & GMP Rules
You might have read so many guidelines and articles on Documentation, in this article, I am not going to explain the same things here.
Departments in the Pharmaceutical Industry: List & Roles
Basic Work functions of the key Departments in the Pharmaceutical Industry
Quality Policy for Pharmaceutical Industry
In this article, we will learn about Quality Policy In the pharmaceutical industry Quality Policy is classified as a level-1 document Importance…
JOB in Pharma
Pharmaceutical Industry contributes to improving the health and wellbeing of society.