QA026: SOP FOR PREPARATION, REVIEW, DISTRIBUTION, RETRIEVAL AND CONTROL OF BATCH MANUFACTURING RECORD (BMR) / BATCH PACKAGING RECORD (BPR)
OBJECTIVE: To define the procedure for the controlled preparation, review, issuance, retrieval, revision and archival of Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) in compliance with Regulatory norm. To ensure that all batch records are accurate, legible, contemporaneous and traceable in line with ALCOA+ data-integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, […]
QA025: SOP FOR DOCUMENT, EQUIPMENT, INSTRUMENT, MATERIALS AND ACCESSORIES NUMBERING SYSTEM
OBJECTIVE: The purpose of this Standard Operating Procedure is to establish a uniform, systematic, and traceable method for assigning document numbers, batch records, equipment/Instrument codes, utility numbers, material codes, and related identifiers to all controlled documents generated under the Quality Management System. SCOPE: This procedure is applicable to all departments of the organization involved in […]
QA024: SOP FOR HANDLING AND DISPOSAL OF REJECTED MATERIAL, EXPIRED FINISHED PRODUCTS, NEAR-EXPIRY PRODUCTS, AND SAMPLES
OBJECTIVE: The purpose of this SOP is to define a uniform and documented procedure for identification, segregation, control, and destruction of rejected materials, expired finished products, near-expiry products, stability samples, control samples, and various laboratory samples in order to prevent their unintended use and ensure compliance with Pharmaceuticals, and environmental regulations. SCOPE: This SOP is […]
QA023: SOP FOR BATCH RELEASE
OBJECTIVE: To establish a uniform procedure for release of each batch of finished product only after verification that it has been manufactured, tested, and documented in accordance with GMP and regulatory requirements. To ensure that no product is dispatched without formal written authorization from the Head QA (Authorized Person). SCOPE: This procedure applies to the […]
QA022: SOP FOR PREPARATION, REVIEW, ISSUANCE, REVISION, ARCHIVAL, RETENTION & DESTRUCTION OF DOCUMENTS & RECORDS
OBJECTIVE: To describe the systematic procedure for preparation, review, approval, issuance, revision, retrieval, archival, retention, and destruction of all controlled documents. To ensure that only current, approved, and authorized versions of documents are available for use within the facility. SCOPE: This SOP applies to all Quality Management System (QMS) documents generated and maintained at company, […]
QA021: SOP FOR INCIDENT REPROTING
OBJECTIVE: To describe the procedure for identifying, documenting, investigating, and reporting any incident or deviation that may impact product quality, Good Manufacturing Practices (GMP) compliance, safety, or regulatory requirements within the pharmaceutical manufacturing facility. SCOPE: Applicable to all departments of the manufacturing site such as Production, Quality Assurance (QA), Quality Control (QC), Engineering, Microbiology, Warehouse, […]
QA020: SOP FOR PREPARATION, REVIEW, AND CONTROL OF VALIDATION MASTER PLAN (VMP)
OBJECTIVE: The purpose of this SOP is to define the procedure for the preparation, review, approval, issuance, and control of the Validation Master Plan (VMP) in compliance with WHO TRS / EU-GMP Annex 15 and other applicable regulatory guidelines. The VMP serves as a high-level document summarizing the site’s validation policy, strategy, responsibilities, scope, and […]
QA019: SOP FOR PREPARATION, REVIEW, AND CONTROL OF SITE MASTER FILE (SMF)
OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to define the procedure for the preparation, review, approval, distribution, and control of the Site Master File (SMF) in accordance with the requirements of WHO / TRS / EU-GMP Part III and other applicable regulatory guidelines. The SMF provides a detailed overview of the site’s […]
QA018: SOP FOR DISASTER RECOVERY PLAN (DRP) FOR GMP-RELEVANT COMPUTARIZED SYSTEMS
OBJECTIVE: To define the documented and controlled procedure for recovery and restoration of GMP-relevant computerized systems following any disaster or system failure, ensuring data integrity, traceability, business continuity, and compliance with WHO TRS / EU GMP Annex 11 and Annex 15. SCOPE: It shall be Applied to: All GMP-critical computerized systems and associated databases. Data […]
QA017: SOP FOR PRODUCT QUALITY REVIEW
OBJECTIVE: To define the procedure for the preparation, review, and approval of Product Quality Review (PQR) in compliance with regulatory, ensuring continued process consistency, product quality, and suitability of current specifications. SCOPE: Applicable to all finished pharmaceutical products manufactured by Company. This SOP covers collection, evaluation, trending, and reporting of production, analytical, and quality data […]