Pharmaceutical Guidance Complete Pharma Solution
What are the different types of Quality Management systems (QMS)? Quality management is an essential …
Read More »OUT OF SPECIFICATIONS (OOS)
SOP for Quality Assurance Policy
S0P OF ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION
RISK MANAGEMENT METHODOLOGY – ICH Q9
TABLE OF CONTENTS – QUALITY RISK MANAGEMENT -ICH Q9 IN PHARMA
DRUGS AND COSMETICS ACT, 1940 FOR MEDICINE
Validation Questions on cleaning validation (APICS)
Cleaning process Control
SOP on Document Management System in Quality Assurance Department.
DOCUMENTATION IN PHARMACEUTICAL
Operation, cleaning and maintenance of Static Pass Box
Functioning, cleaning and maintenance of Static Pass Box. Objective: To lay down the method for …
Read More »STERILITY ASSURANCE
Functioning, cleaning and maintenance of Dynamic Pass Box
Functioning, cleaning and maintenance of Sterile Garment Cabinet
SOP on Operation, Calibration, Cleaning and Maintenance of LAF
Effectiveness of Antimicrobial Preservatives in Pharma industry
All Post URL of Drugs formulations
UV LAMP EFFICACY TEST
UV efficacy Challenge test
SOP on Testing Efficacy of Disinfectants
SOP on Personnel Qualification for Aseptic Processing and Sterility Testing Area
SOP OF SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA
SOP OF SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA AS PER ICH Q6 A GUIDELINE Question …
Read More »Quality Risk Management in Analytical Laboratory
IMPURITIES IN NEW DRUG SUBSTANCES
HPLC (Questions & answers)
Dissolution (Question & Answer)
OOS (Out of Specification) As PER USFDA & MHRA
SOP on Sampling of Raw Material
SOP FOR STABILITY STUDY IN PHARMA INDUSTRY
Total Organic Carbon in Water in Pharma Industry
Indian Pharmacopoeia Commission (IPC)
SOP FOR BUBBLE POINT TEST
All Post URL of Drugs formulations
All Post URL of Drugs formulations Tablets MFR of Albendazole Tablets – (drugsformulations.com) MFR of …
Read More »List of Documents required for Store/warehouse (GMP Compliances)
LINE CLEARANCE CHECKLIST FOR VACUUM CLEANER
Good storage practices for pharmaceuticals as per regulatory Guideline
GUIDE TO INSPECTIONS ORAL SOLUTIONS AND SUSPENSIONS
GUIDE TO INSPECTIONS ORAL SOLUTIONS AND SUSPENSIONS – Oral Solutions and Suspensions (8/94) I. INTRODUCTION The …
Read More »Tablet Defects and Remedial action in Pharma
SOP on Manufacturing Operations and Controls
Batch Manufacturing Record(BMR)
Rubber Bung Processor Cum Sterilizer
Cleaning of Factory Footwear
Sterilization Process Controls
Dry Powder Injection
Key Point of Dry Powder Injection
BATCH MANUFACTURING RECORD OF DRY INJECTION
Lyophilization of Parenteral
All Post URL of Drugs formulations
All Post URL of Drugs formulations Tablets MFR of Albendazole Tablets – (drugsformulations.com) MFR of …
Read More »Pharma USFDA Warning Letter for Lohxa LLC
Pharma USFDA Warning Letter for Derma Pharm A/S MARCS-CMS
Pharma USFDA Warning Letter for OHM Pharma, Inc
Pharma USFDA Warning Letter for Alkermes, Inc.
Pharma USFDA Warning Letter for Pharmalab Enterprises, Inc.
Pharma USFDA Warning Letter for Wild Child WA Pty Ltd.
Pharma USFDA Warning Letter for Unipharma, LLC
Pharma USFDA Warning Letter for LNK International, Inc.
USFDA Warning Letter for Dercher Enterprises, Inc., DBA Gordon Laboratories
USFDA Warning Letter for Cross Brands Contract Filling, LLC
Temperature mapping of storage areas – TRS 961, Annex 9
Temperature mapping of storage areas (WHO Technical Report Series, No. 961, 2011, Annex 9) The …
Read More »Equipment in Pharma company as per USFDA
Production and Process Controls in Pharma industry as per USFDA
Definitions as per 21 CFR 210 (USFDA) in Pharma company
Buildings and Facilities in pharma industry as per USFDA
SOP and Guideline for Hold-Time Studies of Tablets
All Post URL of Drugs formulations
Materials in Pharmaceutical as per WHO Guideline
ICH Q8/Q9/Q10 Questions and Answers
Q7 GMP Guidance for Active Pharmaceutical Ingredients
STABILITY TESTING OF NEW DRUG PRODUCTS Q1A(R2)