Sampling Procedure ,Purpose :
Sampling Procedure , To define the procedures for sampling of all intermediates and finished products.
Sampling Procedure , Scope :
This procedure is applicable for sampling of all intermediates and semi-finished products that are manufactured at XX Pharmaceuticals Limited (Both General and Sterile Block).
Definitions / Abbreviation:
[][]Intermediate Product: Partly processed material which must undergo further manufacturing steps before it becomes a bulk product.
[][]Finished Product: A medicinal product which has undergone all stages of production, including packaging in its final container.
[][]QCOM: Quality Compliance
[][]BMR: Batch Manufacturing Record
[][]BPR: Batch Packaging Record
[][]QC: Quality Control
[][]IPC: In-Process Check
Responsibilities:
[][]The roles and responsibility is as follows:
Executive/ IPC Inspector, Quality Assurance
[][]Responsible for sampling of intermediate, semi-finished (bulk) products as per the procedure
Asst. Manager, Quality Assurance
[][]Responsible for overall execution, supervision, control and implementation of sampling.
Manager, Quality Assurance
[][]Approval of the SOP.
Procedure:
Quantity of Intermediate (semi finished), control sample and stability sample (if any) shall be drawn as stated in the Annexure-I & II
Semi-finished (Bulk) Products Sampling:
[][]QA Executive shall collect the in-process samples.
[][]QA Executive shall ensure the completion of stage prior to sampling.
[][]Check the physical condition and labels on each container for specified details on the drum or container to be sampled.
[][]In case of powders / granules use dry SS sampling rod. Introduce the samplers vertically throughout the length of product and draw the sample from different depths of the product. Mix the sample and take a composite sample in the bag / beaker from each of the container sampled.
[][]QA Executive shall ensure that the specified quantity of sample as per Annexure–I & II is taken.
[][]In case of lubricated granules and blended powders/granules, draw at least three samples from three different locations and at different depths.
[][]LOD on granules should be carried out on mixed samples made from the samples of three locations.
[][]Samples of core tablets or capsules should be drawn at three times (start, middle and end time) of compression or encapsulation and a composite sample should be given to QC for complete analysis.
[][]QA Executive shall be assisted by Production Executive to ensure that the sampled containers are securely sealed after drawing the sample and ensure that the product is not exposed to atmosphere or moisture.
[][]QA Executive shall affix “Quarantine” label to containers and enter the sampling details in the respective Batch Production Record (BMR & BPR) and Sampling Advice Form (SAF) and shall forward the sample to QC for analysis along with SAF.
[][]Final blending sample shall be forwarded to QC for analysis when product strength is below or equal to 2.5 mg.
[][]In different stages parameters to be tested by QC as per finished product specification.
Control Sample / Stability Sampling:
[][]QA Executive shall select the random packed shippers and check the quantity per shipper, pack, label details and draw the sample from the shipper.
[][]QA Executive shall immediately replace the number of units taken as sample with the same number of units from the last shipper.
[][]QA Executive shall be assisted by production Executive to ensure sampled shipper is filled with appropriate quantity and closed properly.
[][]QA Executive shall affix “Quarantine” label on each pallet and enter the sampling details of Control samples and Stability samples in the respective batch records.
[][]The packs sampled, as Control sample shall be individually stamped as ‘Control Sample’ with red ink.
[][]Stability samples shall be charged into stability chamber as per stability plan.
Annexure:
Annexure-I: Intermediate And Semi finished (Bulk) Product Sampling Details (For QC)
Annexure-II: In process Sampling Details (For QA)