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SOP for Raw Material Sampling in Pharmaceuticals

Raw material sampling in the pharmaceutical or SOP for Raw Material Sampling in Pharmaceuticals industry refers to the process of taking a representative sample of a raw material used in the manufacture of drugs to determine its quality and identity. This is important to ensure that the raw material meets the specifications set out in the quality control standards and that it is suitable for use in the manufacture of safe and effective drug products. Raw material sampling is typically performed at the point of receipt, and the samples are analyzed using various analytical techniques such as chromatography, spectroscopy, and microscopy to ensure that the raw material is free from impurities and contaminants.

Raw material sampling in the pharmaceutical industry involves taking a representative sample of a raw material used in drug production and testing it to ensure its quality and identity. This is important to guarantee the safety and efficacy of the final drug product. Sampling is typically performed at the time of receipt and the sample is analyzed using analytical techniques such as chromatography, spectroscopy, and microscopy to verify that the raw material is free from impurities and contaminants and meets established quality control standards.

 

Purpose:

To ensure a procedure for a sampling of Raw Materials to get a representative sample of whole lot/batch for analysis.

Scope:

This procedure is applicable for a sampling all raw materials received at pharmaegg.com.

Responsibilities:

  • QA Manager
  • Inventory Control Manager
  • QA Officer

Precautions:

  1. Run the sampling booth at least 30 minutes before sampling
  2. Clean and mop the area before sampling
  3. Care should be taken to avoid contamination and cross contamination during sampling
  4. Always take sample of one material at one time to avoid cross contamination
  5. Always use Clean and dry sampling tool for each sample to avoid contamination and cross contamination

List of Sampling Tools:

  1. Scoops
  2. Sampling Rods
  3. Pipette
  4. Spatulas
  5. Glass Beakers
  6. Poly bags

SOP for Raw Material Sampling in Pharmaceuticals

Procedure:

QA Manager receives the sampling/testing intimation from the inventory control manager.

QA officer in the presence of Store Person checks the container(s) that it has been placed properly in Quarantine and an identification card “QUARANTINE” (yellow colored) is pasted on each container, also make sure that the information being provided in sampling request is correct or not, according to the identification/information label on container and COA.

Material received must be from an approved vendor, material will not be sampled if it is not from an approved vendor.

Material will be shifted from Quarantine to Sampling Booth before sampling.

Check physical condition of the container for any damage/loose seal or packing, etc.

QA Officer wears mask and gloves before taking the sample.

Keeping in account the sensitivity of material towards light and moisture, QA Officer takes the sample with a sampling rod/pipette to ensure sampling from top, center and bottom of the container.

Sample will be collected in:

  • A poly bag for solids
  • A glass beaker for liquids

For API, all containers will be sampled and identify separately but potency will be of collective sample of same lot/batch.

For excipients, the no. of samples is determined from American Military Standard MIL-STD 105E. The formula of √n + 1, where n= number of containers. This formula will be applicable where no. of containers is more than 4. If no. of containers is 4 or less than 4 then all containers will be sampled.

Sample size is as follows:

For solid raw materials: NLT 2g

For liquid raw materials: NLT 100ml

For flavors (liquids): NLT 50ml

After sampling close each container tightly in proper way and shift back to Quarantine with a “SAMPLED” sticker pasted on it.

QA Officer will enter all the sampling record.

Sample is then handed over to the QC analyst for analysis

Sample is tested and then Quality Control Manger will decide about the release or rejection of the material with respect to testing results.

After release material is labeled with “RELEASED” slip (Green colored) and shifted to release area of raw material store.

If rejected then material is labeled with “REJECTED” slip (Red colored) and shifted to rejected area of raw material store.

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