SOP on Method for Sampling of Raw Materials
1.0 Purpose: This SOP describes the method for sampling and testing of raw materials.
2.0 Scope: This SOP applies to the receiving / warehousing department and Quality Control department.
3.0 Responsibility: Receiving / warehousing department and Quality Control department to follow this procedure.
4.0 Materials and Equipment:
Sampling equipment
Sampling area
5.0 Procedure:
5.1.0 General Requirements –
5.1.1 The raw materials are handled and stored in a manner to prevent cross-contamination.
5.1.2 The materials in the bags or boxes are stored on shelves or on pallets in order to permit cleaning and inspection.
5.1.3 Each container or group of containers for raw materials are identified by a coloured sticker as to its status as follows:-
Yellow sticker – Quarantine
Green sticker – Released
Red sticker – Rejected
5.2.0 Receipt and storage of materials requiring testing or examination by Quality Control
5.2.1 Upon receipt and before acceptance, each shipment is examined visually as to its integrity and proper labeling. The inspection is performed by the warehouse operator in the receiving area, prepares a Goods In-inspection report (GIR) and paste the yellow slip containing all necessary details like – date, product name, B.No., M/D, E/D, Mfd. By, Supplied By etc.
5.2.2 Materials are stored under quarantine until tested or examined, and released or rejected by Quality Control.
5..3.0 Sampling
5.3.1 Representative samples of each shipments of each lot are collected for testing or examination by the Quality Control chemist (Ref. SOP)
5.3.2 Quantity of each sample drawn is at least two times that needed to perform all the tests. Divide the sample in two portions- one for testing and outer part as retention sample.
5.3.3 Sampling is performed by taking all the precautions to prevent contamination.
5.3.4 Samples containers are identified by specifying the date of sample and name of chemist on the yellow slips.
5.4.0 Testing and Approval or Rejection
5.4.1 Each raw material is tested for conformity with all appropriate specifications for purity, strength and quality.
5.4.2 When shipment contains more than one container of same batch number supplied, at least one test is conducted to verify the identity for each raw material container, according to accepted methods.
5.4.3 If shipment contains containers of different batches, each batch is allotted separate analytical report number and tested completely as per the accepted methods.
5.4.4 When the tests performed by the Quality Control are completed, all the documents are signed and transferred back to the warehouse.
5.4.5 For each material, the Quality Control reviews the documents and release the slips / stickers of approved or rejected along with a certificate of analysis.
5.4.6 Upon receipt of test results, the quarantined materials are shifted to “Approved” or “Rejected” materials area.
5.5.0 Retesting: In accordance with shelf life requirements for raw materials, they are retested accordingly. Date and retest sticker is applied by the Quality Control chemist.
5.6.0 Retention Samples: A well identified sample of each raw material tested and released is set aside for retention.
6.0 Reporting: Records are submitted to Quality Assurance Manager for review and approval or rejection of the raw materials.