SOP for Serialization and Traceability Standard Operating Procedure for Serialization and Traceability 1) Purpose This SOP outlines the procedures for implementing serialization and traceability systems for pharmaceutical products to comply with regulatory requirements, prevent counterfeit products, and enhance supply chain visibility. 2) Scope This SOP applies to all pharmaceutical products subject to serialization requirements, including…

SOP for Artwork and Label Approval Standard Operating Procedure for Artwork and Label Approval 1) Purpose This SOP outlines the procedures for the approval of artwork and labeling used in the manufacture and packaging of pharmaceutical products to ensure compliance with regulatory requirements and product specifications. 2) Scope This SOP applies to all artwork and…

SOP for Quality Control of Packaging and Labeling Standard Operating Procedure for Quality Control of Packaging and Labeling 1) Purpose This SOP outlines the procedures for ensuring the quality control of packaging materials and labeling used in the manufacture of pharmaceutical products to ensure compliance with regulatory requirements and product specifications. 2) Scope This SOP…

SOP for Trending and Data Analysis Standard Operating Procedure for Trending and Data Analysis 1) Purpose This SOP outlines the procedures for trending and analyzing data related to quality metrics, deviations, complaints, and other relevant parameters to identify trends, patterns, and potential areas for improvement within the organization. 2) Scope This SOP applies to all…

SOP for Product and Process Improvement Standard Operating Procedure for Product and Process Improvement 1) Purpose This SOP outlines the procedures for identifying, evaluating, and implementing product and process improvements to enhance quality, efficiency, and compliance within the organization. 2) Scope This SOP applies to all pharmaceutical products and manufacturing processes within the organization, including…

SOP for Qualification of Contract Laboratories Standard Operating Procedure for Qualification of Contract Laboratories 1) Purpose This SOP outlines the procedures for qualifying contract laboratories that perform testing, analysis, or other services related to pharmaceutical products to ensure compliance with quality standards and regulatory requirements. 2) Scope This SOP applies to all contract laboratories engaged…

SOP for Quality Agreements with Third Parties Standard Operating Procedure for Quality Agreements with Third Parties 1) Purpose This SOP outlines the procedures for establishing and maintaining quality agreements with third-party suppliers, contractors, and service providers to ensure compliance with quality standards and regulatory requirements. 2) Scope This SOP applies to all quality agreements established…

SOP for Annual Product Quality Review (APQR) Standard Operating Procedure for Annual Product Quality Review (APQR) 1) Purpose This SOP outlines the procedures for conducting annual product quality reviews (APQRs) to evaluate the quality and performance of pharmaceutical products. 2) Scope This SOP applies to all pharmaceutical products marketed by the organization, including finished dosage…

SOP for Product Quality Review Standard Operating Procedure for Product Quality Review 1) Purpose This SOP outlines the procedures for conducting and documenting product quality reviews to evaluate the quality and compliance of marketed pharmaceutical products. 2) Scope This SOP applies to all pharmaceutical products marketed by the organization, including finished dosage forms, active pharmaceutical…

SOP for Regulatory Inspection Readiness Standard Operating Procedure for Regulatory Inspection Readiness 1) Purpose This SOP outlines the procedures for ensuring that the organization is prepared for and can effectively manage regulatory inspections by health authorities. 2) Scope This SOP applies to all personnel within the organization who may be involved in or affected by…