QC Documents and Procedures

1. QC Documents and Procedures

2. Raw Materials and Components • Purchasing / Procurement • Receiving • Sampling • Specifications • Testing • Storage

3. SPECIFICATION CONTROL • Each specification shall be approved, signed and dated, and maintained by QC unit • The following specification shall be minimally maintained and controlled: • Starting materials specification • Process water specification • Intermediate or bulk product where applicable • Finished product specification • Master formula • Batch Manufacturing Record (BMR)

4. SPECIFICATION • Specifications describe the required characteristics or composition of a product or material or test, while test procedure is required to evaluate the specific characteristic performance • These kinds of documents provide the specific details defining : • the quality of incoming materials, • the quality of the production environment, • the quality of the production and control process, and • the quality of the final product. • Specification covers : • starting materials, • intermediate, • bulks and • finished products • All specifications should be approved by authorized personnel (QC manager)

5. STARTING MATERIAL SPECIFICATION • All raw and packaging materials specification should consist of the following data: • Name of material • Name of principle manufacturer or supplier • Description of the material • Testing parameters and acceptance limit • Shelf life and retest date • Technical drawing, if applicable • Special precaution (storage condition & safety condition)

6. RECEIPT • There should be written procedure on receiving, internal labeling, quarantine and storage of starting materials, packaging materials and other materials as appropriate • Upon receiving of the supplied goods, its identity, legibility of batch number, integrity of its primary packaging and seal shall be verified prior to acceptance. • Certificate of Analysis shall be provided by the supplier accompanying the receiving of starting materials • Quarantine goods shall be segregated from “Release” goods • Reject goods shall be stored in a define area with consideration of control access (eg. Locked area)

7. SAMPLING The sample taking shall be done in accordance with written procedure that describe: • The method of sampling • The sampling tools used • The amount of samples to be taken • The type and condition of the sample container to be used (ie. amber glass bottle) • The identification of the container sampled • Special precaution for hazardous materials • The storage condition (if any) • Instruction for cleaning and storage of sampling equipment • Instruction for re-sealing the opened container.

8. SAMPLING PROCESS • Sampling toolssuch as knives, pliers, saws, hammers, wrenches, implements to remove dust (preferably a vacuum cleaner) • Material to re-close the packages (such as sealing tape), as well as self-adhesive labels to indicate that a part of the contents has been removed from a package or container. • Containers due to be sampled should be cleaned prior to sampling if necessary. • There should be a written procedure describing the sampling operation. This should include health and safety aspects of sampling. • The container used to store a sample should not interact with the sampled material nor allow contamination. It should also protect the sample from light, air, moisture, etc., as required by the storage directions for the material sampled. • Microbiology sampling tools shall be sterilised prior to use • Aseptic technique shall be used during sampling

9. SAMPLING PLAN • Raw Material Sampling plan for raw material should be based on defined sampling standard, for example: • the “n plan” is based on the formula n = 1+√N, where N is the number of sampling units in the consignment; • the “p plan” is based on the formula p = 0.4 √N, where N is the number of sampling unit; or • the “r plan” on the formula r = 1.5√N . • reduce sampling plan such as “p plan” shall be considered only when there is established confidence on the material’s uniformity. • the SR plan is based on sampling the square root of the number of containers received plus 1 • Packaging materials and Finished Product Sampling plans for packaging materials should be based on defined sampling standards, for example British Standard BS 6001-1, ISO 2859, ANSI/ASQCZ1.4-1993, or MIL STD 105E.

10. Scoop for solid Dip tube for liquid Spears for bag Weighted container for large tank SAMPLING TOOLS

11. TESTING & ANALYSIS • All tests shall be performed in accordance with the test methods as stated in the specification • Reduce testing rational shall be documented • Test can be performed by in-house laboratory or external laboratory • Where test is performed in-house, laboratory shall be available

12. LABORATORY DATA (1) • QC should maintain adequate analytical records concerning the examination of materials and products. • Such records should include among others: • The result of every test performed, including observations and calculations, relating to compliance with the established specifications (calculations done on scratch paper shall be included in the record). • The source of the specification used. • Signature(s) of the person(s) who performed the quality control procedure. • A final review (eg. laboratory management), the decision taken, and a dated endorsement by a duly authorized expert (eg. supervisor/manager).

13. LABORATORY DATA (2) • Laboratory data must be recorded in a manner that assures its accuracy, authenticity and completeness, preserves its integrity and assures its retrievability • Data recording should be clear, permanent (not pencil) and traceable to the item tested. • Records, either handwritten or equipment/ computer generated, shall be reviewed, signed off and dated. • There should be a written policy about averaging of numbers, cross-outs of mistakes, significant figures, leaving notebook pages or fill-in-the-blank entries empty, etc.

14. RETAIN SAMPLE (1) • Retain sample should be representative of the batch of materials or products from which they are taken. • Retain sample shall be of a size sufficient to permit at least 2 full re-examinations • Retain samples for each batch of finished products shall be retained at a defined period • Finished product should be kept in their final packaging and stored under the recommended condition (eg. Consumer use condition at room temperature)

15. RETAIN SAMPLE (2) • A retain sample log shall be maintained with the sample identification, batch number and its storage location for ease of retrieval • Prior to disposal of retain sample, visual inspection should be carried out

16. CONTROL OF STARTING MATERIAL ACCEPTANCE • All starting materials shall be verified prior to use. • Verification should include the following: • Review of Certificate of Analysis from the manufacturer versus approved specification • Other tests may be conducted as appropriate:- • Identification test / package identification and other characteristic of the material shall be examined. • Primary packaging: No leakage, sharp dents, tear , exposed parts and seal integrity • Legible label and identification and batch number • Frequency: Every batch of manufacturer’s batch

17. Raw and Packaging Materials Are raw materials and primary packaging materials stored and handled in a manner which prevents their mix-up, contamination with microorganisms or other chemicals, or decomposition from exposure to excessive heat, cold, sunlight or moisture? Are containers of materials closed? Are bagged or boxed materials are stored off the floor? Are containers of materials labeled with respect to identity, lot identification and control status? Are materials sampled and tested or examined in conformance with procedures assuring the absence of contamination with filth, microorganisms or other extraneous substances to the extent necessary to prevent adulteration of finished products? Are materials not meeting acceptance specifications properly identified and controlled to prevent their use in product? 17