QA031: SOP FOR LINE CLEARANCE PROCEDURE – PRODUCTION & PACKING AREAS
OBJECTIVE: This SOP describes the procedure for performing and documenting line clearance in manufacturing and packing areas to prevent product mix-up, cross-contamination, documentation errors, and environmental non-compliance prior to commencement of any batch. SCOPE: This procedure shall apply to: Granulation Area Compression Area Tablet Inspection Area Coating Area Blister Packing Area Secondary Packing Area Dispensing […]
QA030: SOP FOR CALIBRATION OF EQUIPMENT, INSTRUMENTS AND MONITORING DEVICES
OBJECTIVE: The objective of this SOP is to define the procedure for internal calibration, external calibration, finalization of calibration frequency, and preparation calibration plans for equipment, instruments, and monitoring devices used in pharmaceutical operations. SCOPE: This SOP applies to all GMP-critical and non-critical equipment, instruments, and monitoring devices installed and used in Production, Quality Control, […]
QA029: SOP FOR ENVIRONMENTAL MONITORING (TEMPERATURE, RELATIVE HUMIDITY & DIFFERENTIAL PRESSURE)
OBJECTIVE: This Standard Operating Procedure shall describe the method for monitoring, recording, and controlling temperature, relative humidity (RH), and differential pressure (DP) in manufacturing, packing, and warehouse areas to ensure compliance with WHO GMP requirements for tablet manufacturing facilities. SCOPE: This SOP shall be applicable to, Tablet manufacturing areas, Primary and secondary packing areas, Raw […]
QA028: Computer System Validation (CSV)
OBJECTIVE: This SOP shall define the system for planning, executing, documenting and maintaining validation of GxP-relevant computerized systems in accordance with EU-GMP Annex 11 and Annex 15. This SOP shall ensure that computerized systems consistently perform as intended, protect data integrity, and do not adversely affect product quality or patient safety. SCOPE: This procedure shall […]
QA027: SOP FOR BATCH NUMBERING SYSTEM AND PRESENTATION OF BATCH NUMBER, MANUFACTURING AND EXPIRY DATES ON PACKING MATERIALS
OBJECTIVE: To establish a uniform and controlled procedure for assigning batch numbers, manufacturing dates, and expiry dates to all batches manufactured at the facility. To define the presentation format and criteria for printing or engraving these details on all relevant packing materials in compliance with EU-GMP documentation requirements. SCOPE: This SOP is applicable to all […]
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, […]