Standard operating procedure for sampling of Raw materials.

1.0 Purpose:

To lay down a procedure for Raw Material Sampling.

2.0 Scope:

This SOP is applicable for Raw Material Sampling in Quality Control department.

3.0 Responsibility:

QC Officer/ /Designee :
• To enter the details in the Raw material inward register as per procedure.

• To ensure the material is receive from the approved vendor by referring the approved vendor list.

• To check the consignment as per checklist.

• To follow status labeling procedure.

• To give the Raw Material sample for Microbiological testing.

• Select the desire pack/containers as per sampling plan.

QC Executive:
• To plan sampling of raw material as per production Priority.

• In case of any discrepancy inform to QC Head/designee.

QC Head/Designee :
• To review and implementation of SOP.

• To ensure compliance of SOP.

• In case of any discrepancy inform QA Head / Warehouse Head.

QA Head/Designee :
• To approve, implement and to ensure compliance of SOP.

4.0 Procedure:

4.1 Instruction:

4.1.1 Use clean and dry sampling devices.

4.1.2 For sampling of any raw material, which include Microbiological limit test, clean the sampling device with 70% IPA.

4.1.3 During sampling follow the gowning procedure.

4.1.4 Material of only one consignment shall be sampled at a time.

4.1.5 Carry out the sampling of In-active raw material first and then followed by the active raw materials in case of sampling of both raw materials are planned.

4.1.6 Make sure that received material is received from approved vendor by referring the approved vendor list.

4.1.7 During raw material sampling activity if power failure, close the raw material container. After reassume the power, start the LAF and record the observation. After fifteen minutes, start the sampling activities.

4.2 Sampling Procedure:

4.2.1 After receipt of the raw material GRN from warehouse, QC Officer/designee shall enter the details in the Raw material inward register and allocate the A.R. number.

4.2.2 QC Executive/designee shall be planning for raw material sampling as per production priority.

4.2.3 QC Officer /designee shall refer the relevant Raw material specification for quantity to be sample and special instruction if any.

4.2.4 QC Officer/designee shall be followed following sampling criteria:

4.2.4.1 For Active Pharmaceutical Ingredients(API):

• Sampling of each container i.e.100%.

4.2.4.2 For Inactive Ingredients:

• √n+1 Formula ( Where n is total number of containers).

4.2.4.3 Example: If a batch having 25 number of containers, total 6 number of container to be sample √n+1 = √25+1 = 5 + 1=6 Nos.

4.2.4.4 Note: If total number of containers shall receive 5 or less than five, sample from each container.

4.2.5 QC Officer/designee shall prepare require status labels (Under Test, Sampled, Sample for analysis)

4.2.6 QC Officer/designee shall go to Warehouse with sampling thief and sampling kit which contain GRN, sampling checklist, status labels, spatula, self sealing poly bag/glass bottle for liquid sample ,cutting tools and scissor.

4.2.7 QC Officer/designee shall verify the consignment against GRN details and fill up the raw material checklist.

4.2.8 In case of physically damaged or open condition packs / containers observation, inform to QA Head/designee. QA Head /designee shall take decision based on condition of packs / containers and inform to QC Officer/designee for sampling of physically damaged packs/ containers separately or shall reject the physically damaged packs/ containers .

4.2.9 QC Officer/designee shall enter in the sampling room following the gowning procedure.

4.2.10 Put ON the sampling booth. Allow the system to run at least for fifteen minutes before initiating sampling activity.

4.2.11 QC Officer/designee shall check the temperature and humidity of sampling room and record in form.

4.2.12 QC Officer/designee shall check calibration of weighing balance.

4.2.13 QC Officer/designee shall arrange the raw material packs/containers which are to be sampled in sampling booth area with help of warehouse assistant.

4.2.14 Open the one pack/container at a time on under LAF. QC Officer/designee shall check physical appearance of materials.

4.2.15 Draw the sample from different levels of pack/container (i.e. from top, middle and bottom) with help of sampling thief / sampling aids in a poly bag. Follow the same procedure for remaining pack/container.
4.2.16 Cross mark the manufacturer Approved label.

4.2.17 Affix duly filled and signed Under test labels on all over the Quarantine Labels near manufacturer label. Affix Sampled labels near right top corner of under test labels.

4.2.18 After sampling, QC Officer/designee shall close the open pack/containers properly and keep it at designated place in Warehouse.

4.2.19 QC Officer/designee shall ensure the cleaning of sampling room and mention the cleaning record.

4.2.20 QC Officer/designee shall ensure the cleaning of sampling aids.

4.2.21 After completion of whole activity of sampling, maintain the sampling log book.

4.3 For Liquid Material Sampling:

4.3.1 QC Officer/designee shall follow the point 4.2.1 to 4.2.5.

4.3.2 QC Officer/designee shall sampling of liquid material at designated area.

4.3.3 QC Officer/designee shall collect the sample in cleaned glass bottles with help of stainless steel liquid sampler.

4.3.4 Cross mark the manufacturer Approved label.

4.3.5 Affix duly filled and signed Under test labels on all over the Quarantine Labels near manufacturer label. Affix Sampled labels near right top corner of under test labels.

4.3.6After sampling, QC Officer/designee shall close the open pack/containers properly and keep it at designated place.

4.3.7 QC Officer/designee shall ensure the cleaning of sampling aids.

4.3.8 After completion of whole activity of sampling, maintain the sampling log book.