FDA – Warning Letter – October 20, 2023

Warning Letter – October 20, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, from February 20 to March 2, 2023. 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 … Read more

Audit checklist for Purified Water System

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 specified. Purified Water in preparations … 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 are processed in a suitable … Read more

FDA 483 Warning Letter Dated MARCH 30

FDA 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, processing, packing, or holding do … 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 as a storage … Read more

Equipment in Pharma company as per USFDA

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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 cleaning and maintenance. Equipment construction … Read more

Production and Process Controls in Pharma industry as per USFDA

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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 CFR 211.111). Control of microbiological … Read more

Definitions as per 21 CFR 210 (USFDA) in Pharma company

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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 terms apply to this part … Read more

Buildings and Facilities in pharma industry as per USFDA

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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 orderly placement of equipment and … 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 ointments. These guidelines do not … Read more

All Post URL of Drugs formulations

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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 Tablet (drugsformulations.com) Norethisterone Tablet (drugsformulations.com) Metformin … Read more

Materials in Pharmaceutical as per WHO Guideline

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Materials in Pharmaceutical as per WHO Guideline Principle. The main objective of a pharmaceutical plant is to produce finished products for patients’ use from a combination of materials (starting and packaging). Materials include starting materials, packaging materials, gases, solvents, process aids, reagents and labelling materials. No materials used for operations such as cleaning, lubrication of … Read more

ICH Q8/Q9/Q10 Questions and Answers

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ICH Q8/Q9/Q10 1.1 For General Clarification Date of Approval Questions Answers 1.0 June 2009 Is the minimal approach accepted by regulators? Yes. The minimal approach as defined in Q8(R2) (sometimes also called ‘baseline’ or ‘traditional’ approach) is the expectation that is to be achieved for a fully acceptable submission. However, the  ‘enhanced’ approach as described … Read more

Q7 GMP Guidance for Active Pharmaceutical Ingredients

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 Guidance for Industry II. QUESTIONS AND ANSWERS A. Scope (1) 1.1: Should GMP according to ICH Q7 be applied for manufacturing steps before the defined API starting material, i.e., steps not identified in grey in Table 1? ICH Q7 does not apply to steps prior to the introduction of the API starting material.  However, there … Read more

STABILITY TESTING OF NEW DRUG PRODUCTS Q1A(R2)

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STABILITY TESTING OF NEW DRUG PRODUCTS Q1A(R2) Drug Product General Photostability Testing Selection of Batches Container Closure System Specification Testing Frequency Storage Conditions Stability Commitment Evaluation Statements/Labeling Drug Product General The design of the formal stability studies for the drug product should be based on knowledge of the behavior and properties of the drug substance … Read more

STABILITY TESTING OF NEW DRUG SUBSTANCES Q1A(R2)

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STABILITY TESTING OF NEW DRUG SUBSTANCES  Q1A(R2) COVER NOTE FOR REVISION OF Q1A(R) The changes made in Q1A(R) that result from adoption of ICH Q1F “Stability Data Package for Registration Applications in Climatic Zones III and IV”. These changes are: The intermediate storage condition has been changed from 30°C ± 2°C/60% RH ± 5% RH … Read more

Pharmaceutical Development as per USFDA

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PHARMACEUTICAL DEVELOPMENT I. INTRODUCTION II. PHARMACEUTICAL DEVELOPMENT A. Components of the Drug Product 1. Drug Substance 2. Excipients B. Drug Product 1. Formulation Development 2. Overages 3. Physicochemical and Biological Properties C. Manufacturing Process Development D. Container Closure System E. Microbiological Attributes F. Compatibility III. GLOSSARY   INTRODUCTION The Pharmaceutical Development  provides an opportunity to … Read more

Cleaning Validation as per APIC Guideline

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ANDA Submissions — Content and CTD Format (USFDA)

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ANDA Submissions — Content and CTD Format (USFDA) TABLE OF CONTENTS  CTD FORMAT  A. Module 1 – Administrative Information  Forms and Cover Letter Administrative Information References Other Correspondence Labeling B.Module 2 – CTD Summaries Quality Overall Summary Clinical Summary C.Module 3 – Quality Drug Substance Drug Product Appendices Regional Information Literature References D.Module 4 – … Read more

FDA – Warning Letter 

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FDA – Warning Letter September 10, 2019 For FDA Warning Letter Click Here –   Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. For more FDA warning Letter Visit: https://pharmaguidances.com/shop/guideline/usfda-warning-letter/ FDA – Warning … Read more