Standard Operating Procedure for Sampling Procedures for Raw Materials and Finished Products
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define procedures for sampling raw materials and finished products within the pharmaceutical manufacturing facility to ensure representative samples for testing and compliance with quality standards.
2) Scope
This SOP applies to all sampling activities conducted for raw materials received, in-process materials, and finished products prior to release. It covers procedures for sample collection, handling, labeling, and documentation.
3) Responsibilities
– Quality Control (QC) Department: Executes sampling procedures and ensures compliance with SOP and regulatory requirements.
– Warehouse Personnel: Assists in sampling activities and provides access to raw materials and finished products for sampling.
– Quality Assurance (QA) Department: Oversees sampling activities, reviews sampling plans, and ensures adherence to procedures.
4) Procedure
4.1 Sampling Plan Development
4.1.1 Develop sampling plans based on regulatory requirements, material specifications, and risk assessment.
4.1.2 Define sampling locations, sample sizes, and sampling frequencies for raw materials and finished products.
4.2 Sample Collection
4.2.1 Obtain representative samples from designated sampling locations using appropriate sampling tools and techniques.
4.2.2 Ensure that sampling personnel are trained in sampling procedures and adhere to aseptic techniques as applicable.
4.3 Sample Handling and Labeling
4.3.1 Label each sample with unique identifiers, including batch/lot numbers, sampling location, date, and sample collector’s initials.
4.3.2 Transport samples to the testing laboratory in suitable containers under controlled conditions to prevent contamination or degradation.
4.4 Sample Documentation
4.4.1 Document sampling activities in sampling records, including sample collection details, deviations encountered, and any special handling instructions.
4.4.2 Obtain signatures from sampling personnel and QA approval for completed sampling records.
4.5 Sample Retention
4.5.1 Retain retained samples in a secure and controlled environment as per defined retention periods and storage conditions.
4.5.2 Establish procedures for the disposal of retained samples upon expiration or as per regulatory requirements.
4.6 Sampling Review and Reporting
4.6.1 Review sampling records for completeness, accuracy, and compliance with sampling plans and procedures.
4.6.2 Prepare summary reports on sampling activities, including deviations, trends observed, and recommendations for process improvement.
4.7 Documentation
4.7.1 Maintain comprehensive records of sampling plans, sampling records, sample handling, labeling, and disposition activities.
4.7.2 Ensure that all records are reviewed, approved, and archived by the QA department in accordance with SOP requirements.
4.8 Reporting
4.8.1 Prepare periodic reports summarizing sampling procedures and activities, including compliance status and any corrective actions taken.
4.8.2 Submit reports to the QA department for review, approval, and archiving.
5) Abbreviations, if any
– QC: Quality Control
– SOP: Standard Operating Procedure
– QA: Quality Assurance
6) Documents, if any
– Sampling Plans
– Sampling Records
– Sample Disposition Records
7) Reference, if any
– FDA Guidance for Industry: Pharmaceutical Quality Systems
– USP <1058> Analytical Instrument Qualification
8) SOP Version
Version 1.0
