HR006: SOP FOR PEST CONTROL
OBJECTIVE: To define a systematic and effective procedure for pest and rodent control within the premises of Caisa Pharma. To ensure the premises remain compliant with WHO GMP hygiene and sanitation requirements. To prevent contamination of products, materials, and documents due to pest activity. SCOPE: This procedure applies to external and internal areas of the […]
HR005: SOP FOR CONTRACTOR AND VISITOR MANAGEMENT
OBJECTIVE: To establish a uniform procedure for the control, entry, identification, supervision, and safety of contractors, service personnel, and visitors entering company premises to ensure product, personnel, and environmental safety as per WHO GMP requirements. SCOPE: This SOP applies to all external personnel — including contractors, suppliers, auditors, consultants, and visitors — who enter manufacturing, […]
HR004: SOP FOR PERFORMANCE APPRAISAL
OBJECTIVE: To establish a uniform system for assessing employee performance in a fair, consistent, and transparent manner, ensuring that all employees are evaluated against predefined criteria related to job responsibilities, GMP compliance, and organizational objectives. SCOPE: This SOP applies to all permanent, and probationary employees of all departments within the organization. RESPONSIBILITIES: Human Resources (HR) […]
HR003: SOP FOR JOB DESCRIPTION AND RESPONSIBILITIES
OBJECTIVE: To establish a systematic procedure for preparing, reviewing, approving, issuing, and maintaining Job Descriptions (JDs) defining roles, responsibilities, and authority of each employee as per WHO GMP requirements. SCOPE: This SOP applies to all employees across all departments (Production, Quality Assurance (QA), Quality Control (QC), Warehouse, Engineering, Human Resource (HR), Environment, Health and Safety […]
HR002: SOP FOR INDUCTION AND ORIENTATION
OBJECTIVE: To define the procedure for systematic induction and orientation of new employees to ensure that all personnel understand the organization’s policies, objectives, WHO GMP requirements, safety, and hygiene practices before commencing work. SCOPE: This SOP applies to all newly joined employees, including permanent, temporary, contractual, and trainees at all departments of the organization. RESPONSIBILITIES: […]
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 […]