QA & QC

In-process checks during Packaging Operation of tablets and capsules OBJECTIVE : To lay down the procedure for in-process checks during 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 : Production …

Numbering System for Qualification Documents, Protocols and Reports Objective  To lay down a procedure for assigning of number for qualification documents, protocols and reports. Scope  This Standard Operating Procedure is applicable for assigning of number for various qualification documents, protocols (validation protocols, various study protocols like stability studies, etc.) and …

Installation, Operational and Performance qualification of Equipment/Instrument. OBJECTIVE : To lay down the procedure for Installation, Operation and Performance qualification of Equipment/Instrument. RESPONSIBILITY : Validation team comprising of representatives from functional department,Engineering department and Quality Assurance department. Head – QA, Head – Engineering and Head of the concerned department to ensure compliance. …

Vendor Development, Qualification, De-qualification and Requalification for Raw Materials & Packing Material Objective:  To lay down a procedure for the approval of vendors for raw & packing material and De-qualification and Re-qualification of existing approved vendors. Scope: This Standard Operating Procedure is applicable for vendor qualification, De-qualification and Re- qualification …

Release of Finished Products Objective : To lay down the procedure for release of finished products. Scope: This SOP covers the responsibility and procedure for the approval and release of Finished Products for distribution. Responsibility Production, Finished Good Store, QC and QA personnel shall be responsible to follow the procedure …

Review of Batch Manufacturing Record Objective: To lay down a procedure for the review of batch manufacturing records.  Scope: This Standard Operating Procedure is applicable for formulation plants of a Pharma company. Responsibility: Officer / Executive, Quality Assurance shall be responsible for reviewing Batch Manufacturing Record. Head – Quality Assurance …

Documentation and Records for GMP Compliance GOOD MANUFACTURING PRACTICES GMP is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. GMP is aimed primarily at diminishing the risk inherent in any pharmaceutical production. Such risks are …

SOP on New Product Design and Development Process The objective of the New Product Design and Development Process : To lay down a Procedure for New Product Design and Development Process. Scope : This Standard Operating Procedure is applicable all pharmaceutical formulation plants of Pharmaceutical Companies. Responsibility Head, Clinical Research: …

SOP On In-process Control of Packing Line 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 shall …

SOP on Sampling of Intermediates and Finished Products 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 shall be responsible for follow the …

SOP On In-process Control During Tablets Manufacturing 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 of pharmaceutical company. RESPONSIBILITY: Production /Quality Assurance Executive/Officer shall Be responsible for follow the procedure mentioned …

SOP on Line Clearances OBJECTIVE : Ensure that the area and equipment, required for the manufacturing and packing activities of pharmaceutical products are free from any potential sources of cross-contamination/ mix-ups. SCOPE: The line clearance procedure is applicable to all activities including dispensing, manufacturing, packaging, and related activities. Responsibility: The …

Objective:To lay down a procedure for the handling of Primary Standard. Scope:This Standard Operating Procedure is applicable to Quality Control Department followed at Pharmaceutical Company name with location. Responsibility:QC personnel shall be responsible to follow the procedure as per SOP. Accountability:Department Head & QA Head shall be accountable for implementation of …

Stability study of volumetric solution Volumetric solutions, called titrants, are meticulously formulated solutions whose concentrations are precisely determined. These are extremely important in quantitative analysis where measurement accuracy is of paramount importance. Prominent examples include standard solutions of acids, bases, and salts used in titrations. These solutions are meticulously prepared …

Good Laboratory practices (GLP) in quality control To define a procedure for Good Laboratory Practices (GLP).  SCOPE This SOP is applicable for quality control department for procedures for Good Laboratory Practices. DEFINITION(S) & ABBREVIATION(S) DEFINITION(S) Good Laboratory Practices (GLP) is a quality system concerned with organizational process and conditions under …

ANALYST QUALIFICATION PURPOSE of ANALYST QUALIFICATION: To lay down the procedure for the qualification of analyst in order to confirm that the newly Joined employee analyst and analyst performing tests in quality control laboratory are adequately qualified to produce reliable and accurate results. SOP SCOPE ANALYST QUALIFICATION: This SOP applicable …

Objective:To lay down a procedure for handling of Out of trend for stability sample Scope:This procedure shall be applicable for handling of out of trend of stability sample at quality control of pharmaceutical company name with location. Responsibility:QC personnel shall be responsible to follow the procedure as per SOP. Accountability:Department Head …

SOP on procurement and handling of working standards Objective:To lay down a procedure for the procurement and handling of working standards. Scope:This SOP is applicable for procurement and handling of working standards in quality control laboratory of pharmaceutical company name with location. Responsibility:Chemist or above of QC laboratory shall be …

SOP on Procedure of Volumetric solution preparation and standardization To lay down a procedure for preparation and standardization of volumetric solution. Scope Of SOP: This SOP is applicable for the preparation and standardization of volumetric solutions in a quality control laboratory in a pharmaceutical company name with location. Responsibility: An …

Raw material SOP on Procedure for a sampling of raw material Objective: To lay down the procedure for sampling raw material. Scope: This procedure is applicable for a sampling of raw material in a Pharmaceutical company name with location. Responsibility: QC personnel shall be responsible for following the procedure mentioned …