In the pharmaceutical industry, OOS (Out of Specification) and OOT (Out of Trend) are critical quality terms used in quality control (QC), laboratory testing, and product release decisions. Understanding the difference between OOS and OOT is essential to ensure regulatory compliance, data integrity, and product quality.
OOS vs OOT in Pharmaceuticals: Key Differences, Examples, and Actions Read More »
This blog explains the types of calibration weights used in pharma, their classifications, and how to select the right weight class based on application needs.
Types of Calibration Weights in the Pharmaceutical Industry Read More »
Glass Grains Test Procedure | Glass Grains Test USP |
Glass Grains Test – USP Read More »
Standard Solutions For Limit Tests Preparation | Limit Tests Solutions Preparation |
STANDARD SOLUTIONS FOR LIMIT TESTS Read More »
GOOD MANUFACTURING PRACTICES FOR ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES)
SCHEDULE M – GMP – PART 2 (OSD) Read More »
SOP for Bursting Strength Tester | SOP for Cleaning and Operation of Bursting Strength Tester |
SOP for Bursting Strength Tester Read More »
Schedule L1 Drugs and Cosmetics Act | Schedule L in Pharma | Schedule L1 Guidelines | GOOD LABORATORY PRACTICES AND REQUIREMENTS OF PREMISES AND EQUIPMENTS General Requirements: Premises: Personnel: Equipments: Chemicals and Reagents: Good house keeping and safety: Maintenance, calibration, and validation of equipments: Reference materials: Microbiological Cultures: Quality system: Internal quality system audits: Management
SCHEDULE L-1 (GLP) Read More »
SOP for Calibration of Gas Chromatography in Pharmaceutical Industry | SOP of Gas Chromatography | GC Calibration | 1.0 OBJECTIVE : 2.0 SCOPE : 3.0 RESPONSIBILITY : 4.0 ACCOUNTABILITY: 5.0 PROCEDURE : 5.1 SAFETY AND PRECAUTIONS: 5.2 PRELIMINARY CHECK BEFORE STARTING THE INSTRUMENT: 5.3 GENERAL SETUP: 5.4 CALIBRATION: 5.4.1 GAS FLOW RATE CALIBRATION: Parameter Set
Calibration of Gas Chromatography SOP Read More »
Pharmaceutical Industry Analyst Qualification Criteria | Analyst Qualification for Quality Control Laboratory | Group Sr. No. Analytical Technique Qualification Procedure Acceptance Criteria A PHYSICAL PARAMETERS (Non-complex Analytical Techniques) 1 Description / Characteristics To be performed on routine sample with Qualified Analyst (single analysis) Individual results must comply with the specifications 2 Solubility 3 Appearance
Analyst Qualification Criteria Read More »
