OBJECTIVE: The purpose of this SOP is to define a uniform and documented procedure for identification, segregation, control, and destruction of rejected materials, expired finished products, near-expiry products, stability samples, control samples, and various laboratory samples in order to prevent their unintended

OBJECTIVE: To establish a uniform procedure for release of each batch of finished product only after verification that it has been manufactured, tested, and documented in accordance with GMP and regulatory requirements.  To ensure that no product is dispatched without formal written

OBJECTIVE: To describe the systematic procedure for preparation, review, approval, issuance, revision, retrieval, archival, retention, and destruction of all controlled documents. To ensure that only current, approved, and authorized versions of documents are available for use within the facility. SCOPE: This SOP

OBJECTIVE: To describe the procedure for identifying, documenting, investigating, and reporting any incident or deviation that may impact product quality, Good Manufacturing Practices (GMP) compliance, safety, or regulatory requirements within the pharmaceutical manufacturing facility. SCOPE: Applicable to all departments of the manufacturing

OBJECTIVE: The purpose of this SOP is to define the procedure for the preparation, review, approval, issuance, and control of the Validation Master Plan (VMP) in compliance with WHO TRS / EU-GMP Annex 15 and other applicable regulatory guidelines.  The VMP serves

OBJECTIVE: The purpose of this Standard Operating Procedure (SOP) is to define the procedure for the preparation, review, approval, distribution, and control of the Site Master File (SMF) in accordance with the requirements of WHO / TRS / EU-GMP Part III and

OBJECTIVE: To define the documented and controlled procedure for recovery and restoration of GMP-relevant computerized systems following any disaster or system failure, ensuring data integrity, traceability, business continuity, and compliance with WHO TRS / EU GMP Annex 11 and Annex 15. SCOPE:

OBJECTIVE: To define the procedure for the preparation, review, and approval of Product Quality Review (PQR) in compliance with regulatory, ensuring continued process consistency, product quality, and suitability of current specifications. SCOPE: Applicable to all finished pharmaceutical products manufactured by Company. This

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,

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

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

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

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

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

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

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