Standard Operating Procedure for Sampling Procedures for Raw Materials and Finished Products
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the sampling of raw materials and finished products within the pharmaceutical manufacturing facility to ensure representative samples for testing and compliance with specifications.
2) Scope
This SOP applies to all personnel involved in the sampling of raw materials and finished products, including Quality Control (QC) and Production personnel. It covers procedures for sampling methods, sample handling, and documentation requirements.
3) Responsibilities
– Quality Control (QC) Department: Performs sampling activities and ensures adherence to SOP and regulatory requirements.
– Production Department: Supports sampling activities and provides access to raw materials and finished products as needed.
– Quality Assurance (QA) Department: Oversees compliance with SOP and reviews sampling records.
4) Procedure
4.1 Raw Material Sampling – QC: Quality Control – Raw Material Sampling Plans – USP General Chapter <1078> Good Manufacturing Practices for Active Pharmaceutical Ingredients Version 1.0
4.1.1 Identify sampling locations and quantities based on sampling plans and specifications.
4.1.2 Use validated sampling methods (e.g., scoop sampling, core sampling) to obtain representative samples.
4.2 Finished Product Sampling
4.2.1 Determine sampling points and sample sizes according to batch size and sampling plans.
4.2.2 Follow approved sampling procedures to collect samples from finished product batches.
4.3 Sample Handling
4.3.2 Transport samples to the QC laboratory promptly under controlled conditions to prevent contamination or degradation.
4.4 Sample Documentation
4.4.1 Complete sampling documentation including sampling location, method used, sample quantity, and any deviations encountered.
4.4.2 Obtain required approvals and signatures for sampling activities from authorized personnel.
4.5 Sample Storage
4.5.1 Store samples in designated quarantine areas with appropriate environmental conditions until testing is performed.
4.5.2 Maintain sample integrity and ensure samples are protected from unauthorized access or tampering.
4.6 Sample Disposal
4.6.1 Dispose of excess or unused samples in accordance with approved procedures and environmental guidelines.
4.6.2 Document sample disposal activities and maintain disposal records as per regulatory requirements.
4.7 Documentation
4.7.1 Maintain accurate and complete records of all sampling activities, including sampling plans, procedures, and sample disposition.
4.7.2 Ensure that all records are reviewed and approved by the QA department.
4.8 Reporting
4.8.1 Prepare reports summarizing sampling activities, including sample collection, handling, and testing results.
4.8.2 Submit reports to the QA department for review, approval, and archiving.
5) Abbreviations, if any
– SOP: Standard Operating Procedure6) Documents, if any
– Finished Product Sampling Procedures
– Sample Disposal Records7) Reference, if any
– FDA Guidance for Industry: Sampling and Testing of in-process materials and drug products8) SOP Version