Author: SARK

About SARK Pharmatech Services SARK Pharmatech Services is a pharmaceutical consultancy and training platform dedicated to supporting pharmaceutical industries, professionals, and students with practical, compliance-focused, and industry-oriented solutions. The organization focuses on delivering reliable support in the areas of: Quality Assurance (QA) Regulatory Affairs (RA) Pharmacovigilance (PV) GMP & cGMP Compliance SOPs and Documentation Systems Validation & Qualification Production and Manufacturing Support Audit Preparation & Compliance Guidance Pharma Training & Skill Development With extensive exposure to pharmaceutical manufacturing environments and regulated market requirements, SARK Pharmatech Services aims to bridge the gap between theoretical knowledge and practical industrial implementation. The platform is committed to simplifying complex pharmaceutical concepts and providing practical guidance for: Pharmaceutical industries Start-up manufacturing units Pharma professionals QA/QC teams Students and freshers entering the pharmaceutical field SARK Pharmatech Services also shares educational and awareness content related to pharmaceutical quality systems, regulatory expectations, documentation practices, validation activities, and industry best practices through training programs and digital platforms. Vision To become a trusted pharmaceutical support platform delivering practical, affordable, and compliance-oriented solutions to the pharmaceutical industry. Mission To help pharmaceutical organizations and professionals overcome operational and regulatory challenges through knowledge, guidance, and practical implementation support. Tagline “One stop solution for all pharma hurdles.”

PV003: SOP FOR SAFETY DATA EXCHANGE AGREEMENTS (SDEA) & PARTNER RESPONSIBILITIES

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 safety responsibilities between the company and external partners for the exchange, reporting, and […]

PV002: SOP FOR PHARMACOVIGILANCE MASTER FILE (PSMF) PREPARATION & MAINTENANCE

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 to all activities related to creating, updating, managing, and maintaining the PSMF for […]

PV001: SOP FOR PHARMACOVIGILANCE (PV) SYSTEM MANAGEMENT & QPPV RESPONSIBILITIES

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 organization, including safety data collection, evaluation, reporting, maintenance of PV system documents, and […]

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 […]