OBJECTIVE: To define the procedure for establishing, reviewing, approving, and maintaining Safety Data Exchange Agreements (SDEA) with all partners involved in safety-related activities. To ensure compliance with World Health Organization (WHO) and European Union Good Pharmacovigilance Practices (EU-GVP) requirements. To clearly define

OBJECTIVE: To define the procedure for preparation, approval, maintenance, and control of the Pharmacovigilance Master File (PSMF) in accordance with World Health Organization (WHO) guidelines, European Union Good Pharmacovigilance Practices (EU-GVP) Module II, and applicable national PV regulations. SCOPE: This SOP applies

OBJECTIVE: To define the system for managing Pharmacovigilance (PV) activities and to describe the responsibilities of the Qualified Person for Pharmacovigilance (QPPV) to ensure compliance with WHO, EU-GVP, and local regulatory requirements. SCOPE: This SOP applies to all PV activities in the

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.

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,

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

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