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.”

QA016: SOP FOR PRODUCT RECALL

OBJECTIVE: To establish a uniform procedure for prompt, efficient, and effective withdrawal or removal of finished pharmaceutical products from the market whenever a quality, safety, or regulatory defect is identified. This SOP ensures full compliance with regulatory expectations, providing for coordination, communication, and documentation of all recall activities. SCOPE: This procedure applies to all finished […]

QA015: SOP FOR DATA INTEGRITY

OBJECTIVE: To define a robust system to ensure that all data generated, recorded, processed, and reported across manufacturing, laboratory, and computerized systems are complete, consistent, accurate, and reliable throughout their entire lifecycle, in compliance with EU GMP, and WHO guidelines on Data Integrity. SCOPE: This SOP applies to all departments involved in the generation, review, […]

QA014: SOP FOR GOOD DOCUMENTATION PRACTICES

OBJECTIVE: To describe the Good Documentation Practices (GDP) to be followed throughout all departments to ensure that all data and records generated, handled, and maintained are complete, legible, traceable, and compliant with EU-GMP, WHO, and national regulatory expectations. SCOPE: All GMP/GLP documentation including Batch Manufacturing and Packaging Records, analytical and laboratory data, logbooks, equipment records, […]

QA013: SOP FOR EXECUTION OF TECHNICAL QUALITY AGREEMENT

OBJECTIVE: To define the procedure for preparation, review, approval, implementation, and periodic review of Technical Quality Agreements (TQAs) between the manufacturing site and external parties (contract manufacturer, contract laboratory, API supplier, or product importer) to ensure compliance with EU-GMP / WHO GMP / local regulatory requirements. SCOPE: This procedure applies to all contract manufacturing, testing, […]

QA012: SOP FOR SUPPLIER QUALIFICATION

OBJECTIVE: To define a risk-based, documented process to evaluate, qualify, approve, and periodically re-qualify suppliers of materials and services so they consistently meet specifications and GMP requirements. SCOPE: Applies to APIs, Excipients, Primary/printed/secondary packaging, Process aids, Lab chemicals, Contract testing, Calibration and HVAC Validation Contract Manufacturing organizations, Distributors Service agreements for Equipment / Instrument in […]

QA011: MARKET COMPLAINT

OBJECTIVE: This SOP establishes a comprehensive and EU-GMP–compliant system for receiving, recording, investigating, and resolving market complaints associated with both own manufactured and imported finished pharmaceutical products handled by Company SCOPE: This SOP applies to all market complaints received from distributors, healthcare professionals, patients, and regulatory authorities concerning products that are either: Manufactured at company […]

QA010: SOP FOR CAPA

OBJECTIVE: This document outlines the procedure for administering corrective and preventive actions (CAPA), including tracking and reporting their status. SCOPE: This SOP is relevant for procedures for tracking, following up on, and verifying the completion and effectiveness of corrective and preventive actions (CAPA). RESPONSIBILITIES: Production Department: Identify and report any deviation, non-conformity, or trend observed […]

QA009: SOP FOR PROCESS VALIDATION

OBJECTIVE: The objective of process validation is to establish documented evidence that a manufacturing process, when operated within defined parameters, is capable of consistently producing a product that meets its predetermined quality attributes and specifications. SCOPE: This procedure applies to: All new products prior to commercial batch release. Existing products when significant changes occur (formulation, […]

QA008: SOP FOR SELF-INSPECTION

OBJECTIVE: The objective of this SOP is to establish a systematic and documented procedure for conducting self-inspections to verify compliance with EU GMP, WHO, FDA, and other applicable regulatory requirements. This SOP ensures: Continuous compliance with cGMP. Early identification of potential gaps affecting product quality, patient safety, and regulatory compliance. Implementation of effective Corrective and […]

QA007: SOP FOR QUALITY MANAGEMENT REVIEW

OBJECTIVE: The objective of this SOP is to outline the procedures for conducting Quality Management Review Meetings. These meetings aim to ensure continuous improvement, compliance with regulatory requirements, and the enhancement of overall quality management practices. SCOPE: This SOP applies to all departments and personnel involved in quality-related activities, including but not limited to Quality […]