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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Residue on ignition / Sulfated ash

Sulphated ash procedure as per BP / IP | Residue on ignition procedure as per USP | Sulfated ash test method | Sulfated ash formula | The Residue on Ignition/Sulfated Ash test uses a procedure to measure the amount of residual substance not volatilized from a sample when the sample is ignited in the presence of sulfuric acid

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Loss on drying

Why loss on drying is performed in pharmaceuticals | Loss on drying procedure | Loss on drying (LOD) is a common test method used in various industries, including food, pharmaceuticals, and manufacturing, to determine the moisture content of a material. The loss on drying test is performed in pharmaceuticals to measure the amount of water and volatile

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Dissolution Test

Dissolution Test Principle : A dissolution test is a pharmaceutical quality control procedure used to determine how quickly and completely a solid dosage form, such as a tablet or capsule, dissolves in a specified liquid medium. The test mimics the conditions inside the human body, where the drug is expected to dissolve in the digestive

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