Audit checklist for Purified Water System Purified water is water that has been mechanically filtered or processed to remove impurities like bacteria, viruses, chemical pollutants, and minerals like lead and copper, Purified Water is intended for use as an ingredient of official preparations and in tests and assays unless otherwise …
Read More »Good Manufacturing Practices (GMPs)
Good Manufacturing Practices (GMPs) CGMPs provide systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Good Manufacturing Practices (GMPs) are the basic manufacturing and environmental conditions required to produce pharmaceutical products. They ensure that ingredients, products, and packaging materials are handled safely and that pharmaceutical products …
Read More »USFDA 483 Warning Letter Dated MARCH 30, 2022
USFDA 483 Warning Letter Dated MARCH 30, 2022 This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21, Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, …
Read More »Temperature mapping of storage areas: Ensuring Reliable Environmental Control and Compliance
Temperature mapping of storage areas: Ensuring Reliable Environmental Control and Compliance In various industries, maintaining proper temperature control within critical areas is essential to ensure product quality, integrity, and regulatory compliance. Temperature mapping of storage areas is a systematic process that involves monitoring and analyzing temperature distribution within a defined space, such …
Read More »Equipment in Pharma company as per USFDA
Equipment in Pharma company as per USFDA Equipment design, size, and location (§ 211.63) in Pharma company Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its …
Read More »Production and Process Controls in Pharma industry as per USFDA
Production and Process Controls in Pharma industry as per USFDA Written procedures; deviations (21 CFR 211.100). Charge-in of components (21 CFR 211.101). Calculation of yield (21 CFR 211.103). Equipment identification (21 CFR 211.105). Sampling and testing of in-process materials and drug products (21 CFR 211.110). Time limitations on production (21 …
Read More »Definitions as per 21 CFR 210 (USFDA) in Pharma company
Definitions as per 21 CFR 210 (USFDA) in Pharma company (a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in Parts 211 through 226 of this chapter for Pharma company. (b) The following definitions of …
Read More »Buildings and Facilities in pharma industry as per USFDA
Buildings and Facilities in pharma industry Design and construction features in pharma industry (a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations. (b) Any such building shall have adequate space for the …
Read More »SOP and Guideline for Hold-Time Studies of Tablets
SOP and Guideline for Hold-Time Studies of Tablets These guidelines focus primarily on aspects that should be considered in the design of the hold-time studies during the manufacture of non-sterile solid dosage forms. Many of the principles described here also apply to other dosage forms such as liquids, creams, and …
Read More »All Post URL of Drugs formulations
All Post URL of Drugs formulations Tablets MFR of Albendazole Tablets – (drugsformulations.com) MFR of Alfacalcidol & Calcium Carbonate Tablets (drugsformulations.com) MFR of Sildenafil Citrate Tablets (drugsformulations.com) MFR of Paracetamol & Dicyclomine HCl Tablets – (drugsformulations.com) MFR of Dextromethorphan, Bromhexine, Chlorpheniramine Maleate & Guaifenesin Tablets (drugsformulations.com) Dextromethorphan (drugsformulations.com) Spiramycin Tablet (drugsformulations.com) MFR of Propranolol Hydrochloride …
Read More »