ICH Guidelines

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an organization that develops guidelines and standards to ensure the global harmonization of the development, registration, and post-approval phases of pharmaceutical products. ICH brings together regulatory authorities and the pharmaceutical industry to create consensus on various aspects of drug development.

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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 class=”has-inline-color has-ast-global-color-0-color”: Equipments: Chemicals and Reagents: Good house keeping and safety: Maintenance, calibration, and validation of equipments: Reference materials: Microbiological Cultures: Quality system: Internal quality system

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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: mark 5.4 CALIBRATION: 5.4.1 GAS FLOW RATE CALIBRATION: Parameter

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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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