Calibration – SOP Guide for Pharma https://www.pharmasop.in The Ultimate Resource for Pharmaceutical SOPs and Best Practices Fri, 14 Apr 2023 14:47:04 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.2 Raw Material Sampling Plan: Procedure for Water Sampling https://www.pharmasop.in/raw-material-sampling-plan-procedure-for-water/ Fri, 14 Apr 2023 14:46:00 +0000 https://www.pharmasop.in/?p=76 The Raw Material Sampling Plan Procedure for Water outlined in this SOP is critical to ensuring the quality and safety of the water used in the manufacturing processes. By following this procedure, the company can ensure that all water used in the manufacturing processes meets the specified quality standards and does not pose any health risks.

Standard Operating Procedure (SOP) Raw Material Sampling Plan: Procedure for Water Sampling

Purpose: To ensure that water used in the manufacturing processes meets the specified quality standards and does not pose any health risks.

Scope: This SOP applies to all water used in the manufacturing processes, regardless of the source or supplier.

Responsibilities:

  1. Quality control personnel are responsible for developing the water sampling plan and conducting the required tests and inspections.
  2. Manufacturing personnel are responsible for following the water sampling plan and ensuring that all water used in the manufacturing processes meets the specified quality standards.

Procedure:

  1. Quality control personnel will develop a water sampling plan that outlines the sampling frequency, locations, and testing methods to be used.
  2. Quality control personnel will collect water samples from the specified locations according to the sampling plan.
  3. The samples will be transported to the laboratory for testing and analysis.
  4. Quality control personnel will conduct appropriate tests and inspections to ensure that the water meets the specified quality standards.
  5. If the water meets the specified quality standards, it will be approved for use in the manufacturing processes.
  6. If the water does not meet the specified quality standards, appropriate corrective actions will be taken, and the water will not be used in the manufacturing processes until it meets the specified quality standards.

Documentation: All documentation related to the water sampling plan, including the sampling frequency, locations, and testing methods used, will be maintained as per the company’s standard record-keeping procedures.

Training: All personnel involved in the water sampling plan procedure will receive training on this SOP to ensure compliance and adherence to the procedure.

Revision History: Any revisions made to this SOP will be recorded in the revision history.

References: Any relevant documents or procedures related to the Raw Material Sampling Plan Procedure for Water will be listed here.

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SOP for Raw Material Receipt Procedure https://www.pharmasop.in/sop-for-raw-material-receipt-procedure/ Fri, 14 Apr 2023 14:39:42 +0000 https://www.pharmasop.in/?p=74 The Raw Material Receipt Procedure outlined in this SOP is critical to ensuring the quality and integrity of the raw materials used in the company’s production processes. By following this procedure, the company can ensure that all raw materials received meet the quality standards set by the company and are stored appropriately to maintain their quality until they are used in production.

Standard Operating Procedure (SOP) Raw Material Receipt Procedure

Purpose: To ensure that all raw materials received at the company premises are properly handled, inspected, and stored to maintain their quality and integrity.

Scope: This SOP applies to all raw materials received at the company premises, regardless of the source or supplier.

Responsibilities:

  1. Receiving personnel are responsible for inspecting the raw materials upon receipt, ensuring they meet the required specifications and are in good condition.
  2. Quality control personnel are responsible for conducting tests and inspections of raw materials to ensure they meet the quality standards set by the company.
  3. Warehouse personnel are responsible for properly storing the raw materials in designated areas and maintaining inventory records.

Procedure:

  1. The receiving personnel will obtain the packing list and verify the quantity and description of the raw materials delivered with the order.
  2. The receiving personnel will visually inspect the raw materials for any damages or defects, and report any discrepancies or issues to the supplier immediately.
  3. The receiving personnel will collect a representative sample of the raw material and forward it to the quality control department for testing and analysis.
  4. Quality control personnel will conduct appropriate tests and inspections to ensure the raw materials meet the company’s quality standards.
  5. If the raw materials meet the required specifications, they will be accepted and stored in the designated area by the warehouse personnel.
  6. The warehouse personnel will update the inventory records to reflect the receipt of the raw materials.
  7. If the raw materials do not meet the required specifications, the supplier will be notified immediately, and appropriate actions will be taken.

Documentation: All documentation related to the receipt of raw materials, including packing lists, quality control reports, and inventory records, will be maintained as per the company’s standard record-keeping procedures.

Training: All personnel involved in the receipt of raw materials will receive training on this SOP to ensure compliance and adherence to the procedure.

Revision History: Any revisions made to this SOP will be recorded in the revision history.

References: Any relevant documents or procedures related to the Raw Material Receipt Procedure will be listed here.

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