QA022: SOP FOR PREPARATION, REVIEW, ISSUANCE, REVISION, ARCHIVAL, RETENTION & DESTRUCTION OF DOCUMENTS & RECORDS
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 applies to all Quality Management System (QMS) documents generated and maintained at company, […]
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, […]