QA & QC

Operating procedure for ultrasonic bath. Quality assurance OBJECTIVE To lay down a procedure for operation and cleaning of ultra sonic bath SCOPE This SOP shall be applicable for operation and cleaning of Ultra sonic bath. RESPONSIBILITY Quality Control Executive/Officer ACCOUNTABILITY Head-Quality Control. PROCEDURE  FOR CLEANING Switch OFF the equipment and …

Calibration procedure for gas chromatograph clarus 500 with headspace (Perkin Elmer) OBJECTIVE To lay down the procedure for calibration of  GC  Clarus 500 with headspace (Perkin Elmer ) SCOPE This SOP shall be applicable for the GC Clarus 500 with headspace (Perkin Elmer). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality …

Area clearance during batch/product change over in Pilot Production facility. Quality Assurance OBJECTIVE : To provide procedure for  Area  clearance during batch/product change over in Pilot Production facility. RESPONSIBILITY : Officer Quality Assurance  for implementation Quality Assurance Manager to ensure compliance. PROCEDURE : Note: (i)  Type-A  Area clearance : During …

Preparation, Approval and Control of Guidelines (Quality Assurance) OBJECTIVE : To lay down the procedure for the preparation, approval and control of Guidelines. RESPONSIBILITY : All the personnel shall to be familiar with this SOP. The approver to ensure that all proposed Guidelines conform to this SOP before approving any …

Technology transfer OBJECTIVE : To  lay down a procedure for technology transfer of New products . SCOPE : The scope of this SOP is to all the new Products for which Technology has been provided by outside party or from R&D. RESPONSIBILITY : Head of Production, QA Head, QC Head  …

Correction of Documentation Errors Objective To lay down a procedure for correcting the errors in documentation. Scope This Standard Operating Procedure is applicable for correction of all documentation error in written procedures (SOPs, Specifications, STPs, or TDs etc.) and records (Batch Manufacturing Records, Raw Data, Log Books, etc.) Responsibility Each …

New Product Design and Development Process Objective To lay down a Procedure for New Product Design and Development Process. Scope This Standard Operating Procedure is applicable all pharmaceutical formulation plants. Responsibility Head, Clinical Research : Conducting Clinical Trials as per the Good Clinical Practices and review and compilation of data …

Approval of vendors (Packing Materials) OBJECTIVE: To lay down a procedure for approval of new vendors for packaging materials. SCOPE: This SOP is applicable to all new manufacturer / suppliers of packaging materials RESPONSIBILITY: Purchase, QC and QA personnel shall be responsible to follow the procedure mentioned in this SOP. …

Vendor Development and Approval (API and excipients) OBJECTIVE : To lay down a procedure for vendor audit for raw material, developing and approving the vendor who can consistently supply the raw materials with right quality and quantity at right time. SCOPE : This Standard Operating Procedure is applicable to approve …

CLEANING VALIDATION FOR DRUG PRODUCTS To establish and explain the procedure to be followed for the Validation of Standard Cleaning Procedures (SOP’s), in order to demonstrate that cleaning procedures are effective, adequate and shall consistently remove the residues (chemical, microbial and cleaning agent, if any) from the equipment to a …

The role of dissolution in drug development Oral dosage forms remain one of the most flexible and effective treatments available to patients. Dissolution testing is a requirement for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability testing. It is a pivotal …

Procedure for operation of Autotitrator (METTLER TOLEDO). Quality assurance OBJECTIVE To lay down the procedure for operation of AUTO TITRATOR (METTLER TOLEDO DL50) SCOPE This procedure is applicable to Autotitrator (METTLER TOLEDO DL50). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control. PROCEDURE FOR CLEANING Check that the power supply to …

PROCEDURE FOR OPERATION OF HUMIDITY CONTROL OVEN (NEWTRONIC). Quality assurance OBJECTIVE To lay down the procedure for operation of Humidity control oven. Model  : NEC 228R 10S SCOPE This SOP shall be applicable for the operation of Newtronic make Humidity control oven (30°C/65%RH) &. (40°C/75%RH) RESPONSIBILITY QA Officer / Executive …

Types of Glass used in Pharmaceutical Industries Parenteral Use Type I Glass: Highly Resistant Borosilicate. Used for Buffered and Unbuffered aqueous solution.Type II Glas: Highly Resistant Sodalime glass. The buffered aqueous solution below pH 7.0Type III Glass: Moderately Resistant Sodalime glass. Used for dry powder and oily solution.Non-Parenteral Use Type …

PROCEDURE FOR MICROBIOLOGICAL MONITORING OF WATER OBJECTIVE:To lay down a procedure for microbiological monitoring of raw water and purified water. SCOPE:This SOP shall provide the procedure for sampling and testing of raw water and purified water from all the user points and all the points across the critical functions in …

RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST Material Name: AR No./MRR No./ Date: SNo. Description Check Point 1 Environmental Conditions Temperature RH 2 Under test label Affixed / Not affixed 3 Packing Packed in carboys / drums Packed in fiber/plastic drums with polybag inside Packed in PP woven …

User requirement specification of stability chamber INDEX Objective Scope Basic of system Control system Temperature controller Humidity controller Pc/ printer interfacing unit Data logger Plc Door access system Control panel Safety controller for low /high temperature Optional accessories Software Water tank Printer Validation documentation Approval OBJECTIVE:    This document is to …

DISINFECTANT VALIDATION TABLE OF CONTENTS Protocol Approval Objective Acceptance Criteria Responsibilities Validation Methodologies Evaluation of test Result Re-validation Frequency Documentation Conclusion PROTOCOL APPROVAL  Name / Designation Prepared By Microbiologist Checked By Microbiology Manager. Quality Control Checked By Microbiology Manager. Quality Control Approved By Plant Manager Manager. Quality Assurance OBJECTIVE: To evaluate …

PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM OBJECTIVE The objective of this study is to determine the efficacy of UV germicidal lamp of Laminar air flow and pass box with known microorganism. This ensure that the UV is effective enough to kill the microorganisms on exposure to …

Unit Dose Sampling Procedure for Blend Uniformity OBJECTIVE To lay down the procedure for collecting unit dose blend samples for evaluation of blend uniformity so as to ensure accurate and consistent sampling. RESPONSIBILITY : Officer – Quality Assurance to collect the samples. Head of Quality Assurance to ensure compliance. PROCEDURE: …