Raw Material Sampling SOP

  Raw Material Sampling SOP

1.0   PURPOSE:

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

2.0    SCOPE:

2.1.         This procedure is applicable for sampling of all raw materials received at __Pharmaceuticals

3.0   RESPONSIBILITY:

3.1.      QA Manager

3.2.      Inventory Control Manager

3.3.      QA Officer

4.0    PRECAUTIONS:

4.1.      Run the sampling booth at least 30 minutes before sampling

4.2.      Clean and mop the area before sampling

4.3.      Care should be taken to avoid contamination and cross contamination during sampling

4.4.      Always take sample of one material at one time to avoid cross contamination

4.5.      Always use Clean and dry sampling tool for each sample to avoid contamination and cross contamination.

5.0    LIST OF SAMPLING TOOLS:

5.1.      Scoops

5.2.      Sampling Rods

5.3.      Pipette

5.4.      Spatulas

5.5.      Glass Beakers

5.6.      Poly bags

6.0    PROCEDURE:

6.1.      QA Manager receives the sampling/testing intimation (F-06-005) from the inventory control manager.

6.2.      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” 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.

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

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

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

6.6.      QA Officer wears mask and gloves before taking the sample.

6.7.      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.

6.8.      Sample will be collected in:

6.8.1.   A poly bag for solids

6.8.2.   A glass beaker for liquids

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

6.10.    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.

6.11.    Sample size is as follows:

6.11.1. For solid raw materials: NLT 2g

6.11.2. For liquid raw materials: NLT 100ml

6.11.3. For flavors (liquids): NLT 50ml

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

6.13.    QA Officer will enter all the sampling record in SLB-07-003.

6.14.    Sample is then handed over to the QC analyst for analysis

6.15.    Sample is tested and then Quality Control Manger will decide about the release or

   rejection of the material with respect to testing results.

6.16.    After release material is labeled with “RELEASED” slip (Green colored) and

  shifted to release area of raw material store.

6.17.    If rejected then material is labeled with `“REJECTED” slip (Red colored) and

  shifted to rejected area of raw material store.

5.0    QUALITY FORMS AND RECORD:

N-A

6.0      Risk Analysis

EVIDENCES OF RECORDS & REFERENCES		Request for QC Analysis Raw Material Sampling Log Book (SLB-07-003)
FORMAL KPIs (Key Performance Indicators)		No. of materials being sampled Sampling Time Record maintenance in Sampling log book
GENERAL RISKS		CONTROL   MEASURES	CUSTODIAN
Risks	Impact
Sampling is not done under LFH	Contamination from outside/ cross contamination	Make sure the running of LFH before sampling	Inventory Control Manager/  QA officer
Identification label of Quarantine/ SAMPLED not pasted	Mixing of Sampled or non-sampled containers	Paste Quarantine Label after receiving the materials and SAMPLED label after sampling
Light/moisture sensitive materials are not handled as prescribed	Material may lose its efficacy/ Analytical testing will be effected	Keep the prescribed method of sampling in account , in order to retain the material safety