OBJECTIVE: The objective of this SOP is to define the procedure for internal calibration, external calibration, finalization of calibration frequency, and preparation calibration plans for equipment, instruments, and monitoring devices used in pharmaceutical operations. SCOPE: This SOP applies to all GMP-critical and

OBJECTIVE: This Standard Operating Procedure shall describe the method for monitoring, recording, and controlling temperature, relative humidity (RH), and differential pressure (DP) in manufacturing, packing, and warehouse areas to ensure compliance with WHO GMP requirements for tablet manufacturing facilities. SCOPE: This SOP

OBJECTIVE: This SOP shall define the system for planning, executing, documenting and maintaining validation of GxP-relevant computerized systems in accordance with EU-GMP Annex 11 and Annex 15.  This SOP shall ensure that computerized systems consistently perform as intended, protect data integrity, and

OBJECTIVE: To establish a uniform and controlled procedure for assigning batch numbers, manufacturing dates, and expiry dates to all batches manufactured at the facility.  To define the presentation format and criteria for printing or engraving these details on all relevant packing materials

OBJECTIVE: To define the procedure for the controlled preparation, review, issuance, retrieval, revision and archival of Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) in compliance with Regulatory norm.  To ensure that all batch records are accurate, legible, contemporaneous and traceable

OBJECTIVE: The purpose of this Standard Operating Procedure is to establish a uniform, systematic, and traceable method for assigning document numbers, batch records, equipment/Instrument codes, utility numbers, material codes, and related identifiers to all controlled documents generated under the Quality Management System.

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