SOPs

SOPs

HPLC Method Validation: Ensuring Reliable and Accurate Pharmaceutical Analysis

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HPLC Method Validation: Ensuring Reliable and Accurate Pharmaceutical Analysis High-Performance Liquid Chromatography (HPLC) is a powerful analytical technique widely used in the pharmaceutical industry for drug analysis, quality control, and research purposes. The reliability and accuracy of HPLC results are crucial to ensuring the safety and efficacy of pharmaceutical products. Method validation is an essential … Read more

Usage of purified water at the user point

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Usage of purified water at the user point OBJECTIVE: To define the procedure for the usage of purified water at the user’s point. SCOPE: This SOP is applicable to Tablet & Liquid section in the formulation. RESPONSIBILITY: Production Supervisor –Implementation of SOP. Workmen –To use purified water as per SOP. ACCOUNTABILITY: Production HEAD PROCEDURE: Open the tape of … Read more

Cleaning and sanitization of Flexible / braided tube/pipe

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Cleaning and sanitization of Flexible / braided tube/pipe OBJECTIVE: To establish a procedure for the use, cleaning, and sanitization of Flexible / braided tube/pipe. SCOPE: This SOP is applicable to all sections of the formulation unit. RESPONSIBILITY:  Department in charge Implementation of SOP. Production Supervisor / Operator To use, clean & sanitize tube as per SOP. S&E … Read more

Non-viable particle count in classified

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Non-viable particle count in classified To establish the written procedure for monitoring of non-viable particle count in the classified Area S mall Volume Parenteral section. DEFINITIONS Clean Area:  An area in which defined environmental control of particulate & microbial contamination, is constructed & used in such a way as to reduce the introduction, generation,& retention … Read more

PRECAUTIONS & GENERAL INSTRUCTIONS IN DISPENSING AREA

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PRECAUTIONS & GENERAL INSTRUCTIONS IN DISPENSING AREA Check and ensure the environmental condition of the area e. Temperature and Relative Humidity are within the acceptable limits i.e. (Temperature NMT 270C, RH NMT 50 %) Use personal protective aids while handling the material. Ensure that the line clearance shall be performed before starting each stage of … Read more

Codeine Phosphate and Chlorpheniramine Maleate Syrup

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Codeine Phosphate and Chlorpheniramine Maleate Syrup Dosage Form – Oral Liquid Dosage Form Average fill – 100 ML Label Claim – Each 5 ml contains: Codeine Phosphate IP             10 mg Chlorpheniramine Maleate IP   4 mg In a pleasantly flavored syrupy base Colour: – Sunset Yellow FCF. Product Generic Name: Codeine Phosphate and Chlorpheniramine Maleate Syrup. … Read more

LINE CLEARANCE FOR THE SUGAR MANUFACTURING AREA

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LINE CLEARANCE FOR THE SUGAR MANUFACTURING AREA BMR is available & complete till Stage. Check the “Status Board” of the area for the following details: Product Name, Batch No., Mfg. Date, Exp. Date, Batch Size, and match with BMR. Verification of cleaning of light fixtures, return air risers, & supply air risers during line clearance … Read more

PRECAUTIONS & GENERAL INSTRUCTIONS IN MFG AREA

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PRECAUTIONS & GENERAL INSTRUCTIONS IN MFG AREA Ensure area and equipment cleanliness before starting the manufacturing operations. Check and ensure that all manufacturing equipment and other required accessories are clean and ready for use. Wear Gloves and Nose masks during all manufacturing processes. Counter-check the weights of all ingredients before using them in the batch. … Read more

Checklist for Precautions during working on Analytical Weight Balance (Before weighing)

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Checklist for Precautions during working on Analytical Weight Balance (Before weighing) Checklist for Do’s Check calibration of balance before  weighing Always ensure that the spirit level of the analytical balance is proper. Check silica gel for activation (dark blue) if not then dry it in the Oven till the color changes to dark blue. Use a … Read more

Procedure For Quality Risk Management

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STANDARD OPERATING PROCEDURE Title: Procedure For Quality Risk Management Department: Quality Assurance OBJECTIVE  This SOP defines the approach to Quality Risk Management (QRM) of a GMP  site which may be used to facilitate the process and to aid personnel performing the assessment. SCOPE Applicable to any process at a GMP site that requires a Risk … Read more