Responsibilities of Quality Assurance Department

Responsibilities of the Quality Assurance Department OBJECTIVE : To lay down the responsibilities of the Quality Assurance Department. RESPONSIBILITY : All personnel of the Quality Assurance Department. Head of Quality Assurance Department to ensure compliance. PROCEDURE : The Quality  Assurance  department  shall   be  responsible to formulate systems for the implementation of cGMP and, to ensure … Read more

Procedure for calibration of HPLC (WATERS ALLIANCES)

Procedure for calibration of HPLC (WATERS ALLIANCES) In the pharmaceutical industry, where precision and accuracy are non-negotiable, High-Performance Liquid Chromatography stands as a stalwart technology. From drug development to quality control and regulatory compliance, HPLC plays a vital role in ensuring the safety, efficacy, and consistency of pharmaceutical products. As technology continues to advance, HPLC … Read more

Procedure for operation of IR Spectrophotometer (SHIMADZU)

OBJECTIVE To lay down the procedure for operation of Fourier Transform Infrared Spectro-photometer (Shimadzu) SCOPE This SOP shall be applicable for Quality Control in Quality Assurance department. RESPONSIBILITY  Quality Control Executive/Officer. ACCOUNTABILITY Quality Control Manager. PROCEDURE FOR CLEANING Check that the power supply to the instrument is switched ‘ OFF ‘ before cleaning. Clean the … Read more

Collection, Storage and Control of Reserve Samples for Drug Products

Collection, Storage, and Control of Reserve Samples for Drug Products OBJECTIVE : To lay down a procedure for collection, storage, retrieval, and disposition of reserve samples of drug products. RESPONSIBILITY : Quality Assurance Officer for collection, storage, retrieval, and disposal of reserve samples. Head of  Quality Assurance Department to ensure compliance. PROCEDURE : Every batch/lot … Read more

Correction of Documentation Errors

OBJECTIVE : To provide a procedure for correction of any documentation error, occurred during  documenting  data  in  operating  departments (like  Quality  Control, Production, Warehouse, Engineering, QA) RESPONSIBILITY : Personnel of concerned department to implement. Heads  of concerned departments to ensure compliance. PROCEDURE : All personnel shall avoid making data entry errors. In case an entry … Read more

In-process checks during Packaging Operation of tablets and capsules

OBJECTIVE : To lay down the procedure for in-process checks during the packaging operation of tablets and capsules. RESPONSIBILITY : Officer-Production Packaging. Head of Production Department. Officer-Quality Assurance Head of Quality Assurance Department to ensure compliance. PROCEDURE Inspection of Packaging Materials : The production Officer and QA-Officer shall check that the packaging components issued  (containers, … Read more

Installation qualification for WFI generation plant

Installation qualification for WFI generation plant  RESPONSIBILITES Inspection  Customer or their authorized representatives are responsible for this SAT document. All documents shall be checked and approved by QA or their authorized representatives. Production personal will perform this test. OBJECTIVE To confirm, by physical inspection and testing, that the fabrication and assembly of the equipment and … Read more

Assigning of expiry date to a finished product

OBJECTIVE : To lay down the procedure to assign expiry date to a finished product. RESPONSIBILITY : Officer  Production/Officer Quality Assurance Head – Quality Assurance to ensure compliance. PROCEDURE Manufacturing date : The date of manufacture of the batch shall be the date on which an active ingredient has been added to a batch. Expiry … Read more

Technical training and evaluation of Quality Assurance Officers.

OBJECTIVE : To lay down the procedure for training and evaluation of QA Officers on SOPs  and cGMP. RESPONSIBILITY : Personnel  who   are  knowledgeable  with   the  subject  by  virtue  of  their qualification and experience. Head -Quality Assurance to ensure compliance. PROCEDURE : All Quality Assurance Officers shall undergo training and qualify on relevant/appropriate   Standard Operating   … Read more

SOP on In-process control of packing Process in Pharmaceutical company

OBJECTIVE To ensure quality of Finished Products during strip packing and final packing operation of tablets. SCOPE This SOP shall be applicable in-process controls during primary and secondary packing operation of tablets. RESPONSIBILITY In process Quality Assurance Officer / Executive. ACCOUNTABILITY Head Quality Assurance PROCEDURE START UP Inspect the following areas as per SOP  for … Read more

SOP on Procedure for microbiological monitoring of Purified water in pharmaceutical company

OBJECTIVE   To lay down a procedure for microbiological monitoring of raw water and purified water SCOPE: This SOP shall be applicable for sampling and microbial analysis of raw and purified water from all user points. RESPONSIBILITY  Quality Control Executive / Officer ACCOUNTABILITY Quality Assurance Head. PROCEDURE: Sampling of water Sampling of water from various points … Read more

SOP on Procedure for viable air monitoring in pharmaceutical company

SOP on Procedure for viable air monitoring in pharmaceutical company OBJECTIVE To lay down a procedure for environmental monitoring of air. SCOPE This SOP shall provide the procedure for monitoring the viable air borne count. RESPONSIBILITY Quality Control Executive / Officer. ACCOUNTABILITY Head Quality Assurance. PROCEDURE The microbial environmental conditions shall be monitored by Settle … Read more

SOP on In-process control during tablet manufacturing in Pharmaceutical company

OBJECTIVE To lay down the procedure for In-process Controls during Tablet Manufacturing. SCOPE This SOP shall be applicable for in-process controls during tablets manufacturing This SOP shall be applicable to IPQA in Quality Assurance Department. RESPONSIBILITY In process Quality Assurance Executive/Officer. ACCOUNTABILITY Head Quality Assurance. PROCEDURE Carry out line clearance at each stage of operation prior … Read more

SOP on Sampling of intermediates and finished products in pharmaceutical company

OBJECTIVE To lay down a procedure for sampling of intermediate(blend/core/coated/capsules) and finished products (packing)during manufacturing operations. SCOPE This SOP shall be applicable to the IPQA in Quality Assurance Department. RESPONSIBILITY In process Quality Assurance Executive/Officer ACCOUNTABILITY Head Quality Assurance PROCEDURE PREPARATION On completion of intermediate / finished product stage, check that the BMR /BPR is … Read more

Procedure for line clearances. Quality assurance

Procedure for line clearances. Quality assurance OBJECTIVE To ensure that the area, equipment and activities required for the manufacturing and packing of pharmaceutical products are free from any potential sources of cross-contamination/mix-ups (Line clearance). SCOPE The line clearance procedure is applicable to all the activities including dispensing, manufacturing, packaging and related activities. Responsibility In – … Read more

SOP on Sampling of raw materials in pharmaceutical company

OBJECTIVE To lay down a procedure for sampling of Raw Materials so as to get a representative sample of the whole lot for analysis. SCOPE This SOP shall be applicable to sampling of all Raw materials. RESPONSIBILITY Quality Control Executive/Officer ACCOUNTABILITY Head Quality Assurance PROCEDURE On receipt of the Goods Receipt Note (GRN) from warehouse, … Read more

SOP on Samping of packing materials in Pharmaceutical company

OBJECTIVE To lay down a procedure for sampling of packaging materials. SCOPE To describe the procedure for sampling of Primary packing materials i.e. Aluminium Foil, Blister Aluminium Foil, PVC Film etc. and secondary packing materials i.e. Cartons, labels, Leaflet shipper etc. RESPONSIBILITY Quality Control Executive/Officer ACCOUNTABILITY Quality Assurance Manager PROCEDURE On receipt of the Goods … Read more

SOP on Procedure for cleaning and storage of sampling devices

OBJECTIVE  To lay down the procedure for Cleaning and storage of sampling devices. SCOPE This SOP shall be applicable for  Cleaning of all type of Sampling devices. RESPONSIBILITY Quality Control Technician ACCOUNTABILITY Executive / Officer – Quality Control PROCEDURE After the sampling, keep the sampling devices (Sampling rods, sampling spoons and spatulas) in a poly … Read more

SOP on Procedure for operation and cleaning of unit dosage sampler

SOP on Procedure for operation and cleaning of unit dosage sampler Precision and accuracy are paramount In pharmaceutical manufacturing, Ensuring that each dosage of a medication contains the correct amount of active ingredient is essential for both patient safety and regulatory compliance. To achieve this level of accuracy, pharmaceutical companies rely on various tools and … Read more

SOP on Handling of Out of Specification Results in quality control

SOP on Handling of Out of Specification Results in quality control OBJECTIVE To lay down a procedure for handling of Out-of-Specification (O.O.S.) test results generated during the testing. SCOPE These procedures are applicable to all QC testing of raw materials, finished product, and stability samples. RESPONSIBILITY Analyst/ Quality Assurance Manager ACCOUNTABILITY Quality Assurance Manager PROCEDURE … Read more