HR013: SOP FOR ENTRY AND EXIT PROCEDURE FOR MANUFACTURING BLOCK
OBJECTIVE: To define the controlled procedure for entry and exit of personnel into/from the manufacturing block. SCOPE: Applicable to all personnel entering or exiting the manufacturing block. RESPONSIBILITIES: All Personnel: Follow the procedure strictly Production/Area Supervisor: Ensure compliance during entry and exit. Human Resources (HR): Monitoring, and compliance verification DEFINATIONS: NA PROCEDURE: Entry Procedure into […]
HR012: SOP FOR PREPARATION AND CONTROL OF ORGANIZATIONAL CHART (ORGANOGRAM)
OBJECTIVE: To establish a procedure for preparation, approval, maintenance, and revision of the organizational chart (organogram) to ensure a clear definition of reporting structure, roles, and responsibilities in compliance with WHO GMP requirements. SCOPE: This SOP applies to the preparation, control, review, and updating of the organizational chart for all departments including: Production Quality Assurance […]
HR011: SOP FOR SPECIMEN SIGNATURE
OBJECTIVE: To establish a procedure for preparation, control, issuance, and maintenance of Specimen Signature Records of all authorized personnel involved in GMP activities. SCOPE: This SOP shall be applicable to all personnel authorized to sign GMP documents and any other documents related to the Company RESPONSIBILITIES: Concerned Department Head: Shall ensure submission of authorized personnel […]
HR010: SOP FOR MEDICAL CHECK UP
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.
HR009: SOP FOR USAGE OF HAND DISINFECTANTS
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 the stock of hand disinfectant. To ensure existence of hand disinfectant in all […]
HR008: SOP FOR CHANGE IN PERSONNEL (ROLE / RESIGNATION / TRANSFER)
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, or interruption in GMP activities during personnel changes. SCOPE: This SOP applies to […]
HR007: SOP FOR PERSONAL HYGINE
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 visitors involved in manufacturing, quality control, engineering, warehousing, and ancillary services at the […]
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) […]