Amendment status not verified — confirm the current text below against the official source.
Standard Operating Procedures (SOPs) and Records, regarding: 22.1 Receipt of materials: 22.1.1 There shall be written Standard Operating Procedures and records for the receipt of each delivery of raw, primary and printed packaging material. 22.1.2 The records of the receipts shall include; (a) the name of the material on the delivery note and the number of containers; (b) the date of receipt; (c) the manufacturer’s and/ or supplier’s name; (d) the manufacturer’s batch or reference number; (e) the total quantity, and number of containers, quantity in each container received; (f) the control reference number assigned after receipt; (g) any other relevant comment or information. 22.1.3 There shall be written standard operating procedures for the internal labelling, quarantine and storage of starting materials, packaging materials and other materials, as appropriate. 22.1.4 There shall be Standard Operating Procedures available for each instrument and equipment and these shall be placed in close proximity to the related instrument and equipment. 22.2 Sampling: 22.2.1 There shall be written Standard Operating Procedures for sampling which include the person(s) authorized to take the samples. 22.2.2 The sampling instructions shall include: (a) the method of sampling and the sampling plan, (b) the equipment to be used, (c) any precautions to be observed to avoid contamination of the material or any deterioration in its quality, (d) the quantity of samples to be taken, (e) instructions for any required sub-division or pooling of the samples, (f) the types of sample container to be used, (g) any specific precautions to be observed, especially in regard to sampling of sterile and hazardous materials. 22.3. Batch Numbering: 22.3.1 There shall be Standard Operating Procedures describing the details of the batch Drugs and Cosmetics Rules, 1945 401 (lot) numbering set up with the objective of ensuring that each batch of intermediate, bulk or finished product is identified with a specific batch number. 22.3.2 Batch numbering Standard Operating Procedures applied to a processing stage and to the respective packaging stage shall be same or traceable to demonstrate that they belong to one homogenous mix. 22.3.3 Batch number allocation shall be immediately recorded in a logbook or by electronic data processing system. The record shall include date of allocation, product identity and size of batch. 22.4. Testing: 22.4.1 There shall be written procedures for testing materials and products at different stages of manufacture, describing the methods and equipment to be used. The tests performed shall be recorded. 22.5 Records of analysis: 22.5.1 The records shall include the following data: (a) name of the material or product and the dosage form, (b) batch number and, where appropriate the manufacturer and/ or supplier, (c) references to the relevant specifications and testing procedures, (d) test results, including observations and calculations, and reference to any specifications (limits), (e) dates of testing, (f) initials of the persons who performed the testing, (g) initials of the persons who verified the testing and the detailed calculations, (h) a statement of release or rejection, and (i) signature and date of the designated responsible person. 22.5.2 There shall be written standard operating procedures and the associated records of actions taken for: (a) equipment assembly and validation (b) analytical apparatus and calibration, (c) maintenance, cleaning and sanitation; (d) personnel matters including qualification, training, clothing, hygiene; (e) environmental monitoring; (f) pest control; (g) complaints; (h) recalls made; and (i) returns received.