This SOP applies to all employees, contractors, trainees, and temporary staff working within the organization, including production, warehouse, quality control, quality assurance, engineering, microbiology, administration, and support functions.

OBJECTIVE: To lay down the procedure for usage of hand disinfectant solution. SCOPE: This SOP applies to all employees of Caisa Pharma, including permanent, contractual, trainees, and temporary personnel entering in the Manufacturing area. RESPONSIBILITIES: Human Resource Department (HR): Responsible for maintaining

OBJECTIVE: To define a uniform, controlled procedure for handling any change in personnel, including change of role, resignation, or interdepartmental transfer.  To ensure continuity of responsibilities, proper documentation, and compliance with GMP and company policies.  To prevent loss of information, unauthorized access,

OBJECTIVE: To define and implement personal hygiene standards for all employees and visitors entering or working within manufacturing, warehouse, laboratory, and support areas to prevent product contamination in accordance with regulatory requirements. SCOPE: This SOP applies to all employees, contract workers, and

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

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

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,

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

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,

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

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

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

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

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

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

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.