Quality control

SCHEDULE L-1 (GLP)

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

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Calibration of Gas Chromatography SOP

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

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Analyst Qualification Criteria

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

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