QA & QC

Objective:To lay down the procedure for calibration of laboratory glassware. Scope:This SOP is applicable for calibration of laboratory glassware in Quality Control Department at pharmaceutical company name with location. Responsibility:Chemist or above of QA shall be responsible to follow the procedure mentioned in this SOP. Accountability:Department Head & QA Head …

PRODUCT RECALL AND MOCK RECALL PROCEDURE To define the procedure for drug product recall and mock recall. SCOPE This SOP shall be applicable to, Hold or recall of drug products from distribution or market due to certain non-confirmatory aspects or instruction from regulatory agency. Hold or recall of drug products …

Sop on Corrective and Preventive Action Objective : To lay down a procedure for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and /or encountered non-conformities in order to prevent their occurrence and/or recurrence. Scope : This Standard Operating Procedure shall apply to all …

Sop on Recording of Specimen Signature Objective : To lay down the procedure to record the specimen signature. Scope: This Standard Operating Procedure is applicable for the recording of specimen signatures of all the personnel working at Pharmaceutical Company (Name). Responsibility Concerned personnel of all departments shall be responsible for …

HANDLING AND MANAGEMENT OF PRODUCT COMPLAINT To define a procedure for handling of market complaints. PRODUCT COMPLAINT SOP SCOPE  This SOP shall be applicable to all the market complaints of drug products received directly or from any other source. DEFINITIONS Complaint: A market / consumer complaint is notification that a …

HANDLING OF CHANGE CONTROL Change Control: Review, evaluation, approval and monitoring of changes to processes, procedures, specifications, analytical methods, vendors, machines, facilities and utilities. The change can be permanent or temporary. Permanent Change: Any planned introduction, addition, deletion or modification of Manufacturing Facility, Equipment, Utilities, Manufacturing Process, Material/Product, Specifications, and …

Sop on Assigning Manufacturing and Expiry date To lay down a procedure for assigning manufacturing and expiry dates to the finished products being manufactured. & This SOP is applicable for assigning manufacturing and expiry dates to the finished products being manufactured at (Pharmaceutical Company Name). Assigning Manufacturing and Expiry date – …

SOP Template: Operating Standard Procedure SILDENAFIL CITRATE TABLETS Purpose: Mention the intended use of the SOP in this column. It is a statement, which justifies the need of the SOP. Scope: Mention the application of the SOP in this section. It shall describe the extent of areas covered by the …

Standard Operating Procedure – How to Create an Effective SOPs Purpose: Purpose as first point; an overview of the intention of preparation of Standard Operating Procedure shall be briefly mentioned under this heading. SILDENAFIL CITRATE TABLETS Scope: Scope as second point; describes the site(s) / location(s) / plant(s) and/ or …

SOP ON SOP-STANDARD OPERATING PROCEDURE/GENERAL TEST PROCEDURES PURPOSE: To describe a procedure for preparation, review, approval, revision and control of Standard Operating Procedures and General Test Procedures. SCOPE: Applicable to all Standard Operating Procedures and General Test Procedures. RESPONSIBILITY: Author/ Initiator of respective section shall be responsible for preparation or …

Product Quality Review (PQR)/Annual Product Quality Review APQR: Annual Product Quality Review – An organized and Comprehensive summary of a product, analytical and Customer data associated with a pharmaceutical product. Quality trends: Quality trends which include in-process and quality control data should be prepared and alert limits (trend limits) should be established …

Handling of Deviations SOP Any non-conformance /disobedience in written approved procedures (like standard operating procedure, standard test procedure, BMR, etc.) of the quality system in the organization is called deviation. SILVER SULPHADIAZINE AND CHLORHEXIDINE CREAM Objective of Deviations : To describe a procedure for handling deviations that may occur during the execution …

Cleaning Policy of Area & Equipment SOP Objective: To lay down the procedure for the Cleaning Policy of the Area & Equipment. Scope: This Standard Operating Procedure is applicable to all the departments at the formulation plant. Responsibility The production Operator/ Technician shall be responsible for cleaning. Production & QA …

Objective of Good Documentation Practices : To lay down the procedure for Good Documentation Practices in the facility. Scope: This standard operating procedure applies to all departments involved in documentation activities throughout the facility of the Pharmaceutical Company. Responsibility: All employees of Quality Assurance, Quality Control, Production, Warehouse, Engineering, Personnel …

SOP FOR TEMPLATE FOR PROCESS VALIDATION PROTOCOL IN PHARMA CONTENTS of PROCESS VALIDATION PROTOCOL Protocol Approval Sheet Objective Scope Responsibility Validation Team Members Abbreviations Pre-requisite for Validation Manufacturing Procedure Under Validation Critical Process Steps and Process Parameters for Validation with Justification Process steps – Sampling and Analysis Plan with Acceptance Criteria …

SOP on Media Preparation Objective: To lay down the procedure for Preparation of Media. Scope: This SOP is applicable for preparation of sterile media used in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility: Microbiologist or above of Microbiology Laboratory. Head – Microbiology section. Accountability: Head – Quality Control Head – …

SOP on operation, cleaning and maintenance of the Steri-check system Objective: To lay down a procedure for operation, cleaning and maintenance of the Steri-check system. Scope: This SOP is applicable to Steri-check system present in the microbiology lab of (Pharmaceutical Company Name). Responsibility: Officer or above of Microbiology Laboratory: Head …

SOP of Hot Air Oven Objective To lay down the procedure for Operation, Calibration, Cleaning and Maintenance of Hot Air Oven.  Scope This SOP is applicable for Operation, Calibration, Cleaning and Maintenance of Hot Air Oven in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Officer or above of Microbiology Laboratory. …

SOP of Vortex mixer Objective To lay down the procedure for Operation and Cleaning of Vortex mixer  Scope This SOP is applicable for Operation and Cleaning of Vortex mixer in Microbiology Laboratory. (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability Head …

SOP of Media Decontamination and Disposal after used Objective To lay down the procedure for Decontamination and Disposal of Used Media  Scope This SOP is applicable for Decontamination and Disposal of Used Media. (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability …