LAB-060 Laboratory Testing and Documentation of Raw Materials

1. Sampling of Raw Materials

1.1.  Raw Materials include chemicals, components and printed materials.

1.2.  Raw Materials are sampled by trained Warehouse Samplers according to SOP WAR-045 and SOP WAR-050.

1.3.  Raw Material samples are collected in appropriate sample containers and delivered to the Laboratory.

2. Location of Raw Materials

2.1.  Raw Materials to be tested are delivered to the Raw Material sample shelf in the laboratory with accompanying Raw Material Specification and Test Report, Goods Receipt Slip and Manufacturer’s Certificate of Analysis. (See WAR-010).

2.2.  An entry is made into the Raw Material Register form (Form-255) as soon as the samples arrived into the laboratory.

3. Pre-Testing

3.1.  Raw Materials are tested to the FI/FO (First in/First out) principle or urgency unless specifically requested as a priority.

Information regarding the Raw Material is documented on the sample container, Goods Receipt Slip and Raw Material Specification and Test Report sheet.  The Raw Material is assigned an unique Laboratory batch number which will be same in the containers and GRS slip.

3.2.  Controlled Test methods for Raw Material Specifications-Test Report for chemicals are located in the Raw Material filing cabinets and are filed alphabetically.

Controlled Test methods for Packaging Material Specifications-Test Report are filed in Material Code Number order on the packaging material shelves.

Note: Any Raw Material Specification found to contain an error should be brought to the attention of the Laboratory Manager immediately.

To correctly verify the Raw Material against the Raw Material Specification-Test Report:

3.2.1. Sample verification:
Check the code number, name, batch number on the sample container is identical to the information contained on the Specification-Test Report. Check the Code number, Name, Supplier, Manufacturer and manufacturer’s lot number matches with GRS supplied and the Specification report.

3.2.2. Specification report and Test Methods verification:
Check the test method number for the specific tests listed on the Specification report matches with that of test methods.  Check that the quantity required for testing in the Raw Material Specifications matches the quantity sampled.

3.3.  Raw Materials with Manufacturer’s Batch Number that have been previously received, require reduced testing according to the Raw Material Specification.

3.4.  Raw Materials qualifying for extension of expiry date also require reduced testing according to Raw Material Specification (see SOP LAB-005).

3.5.  To check if a chemical Raw Material has been previously received check Laboratory Raw Material Register Log (Form-255).

4. Documentation of Results

A workbook is a legal document and should be treated with care.  All results should be entered in the manner specified in SOP LAB-025.

4.1. A numbered workbook including numbered pages is required to document/log all testing information, including repeats and how the problem was solved for the repeat testing to become an acceptable results.

4.2.  It is not required to write all the testing steps or methods in the workbook, only those steps that require measurements that affect a calculated result.

4.3.  Tests, e.g. Identity and Limit tests can be directly entered onto the Specification-Test report.  Terms such as “negative”, “positive” and “conforms” should be used to describe Limit and Identity tests. All entries on the Specification-Test report should be signed and dated.

4.4.  All calculations are to be entered into the Technician’s workbook and the Specification-Test report.

4.5. Information required in a workbook:

– Raw Material name and Material Number, Lab. batch number, testing date and all raw testing data, e.g. weights, volume.

– The information regarding the standard used in the testing should be written down,
e.g. Batch Number, Expiry Date and assay.

4.6. See SOP QMS-020.  All data is to be neat and legible.  There are to be no scribbles, no liquid paper and all calculations are to be clearly shown.  Pencil is not to be used.  Any mistake should be crossed out neatly, dated and initialled.  Corrections on the Specification-Test report are to be initialled and dated.

4.7. All results, which are generated by a computer printout, (e.g. UV/VIS, FTIR, Polarimeter etc), should be attached to the Specification-Test report.

4.8.  A raw material trend card (Form-265) is assigned for each single raw material. Laboratory staff has to fill up the test results accordingly form the workbooks and sign the card.

5. Testing of Raw Materials

There are associated authorised SOPs, Raw Material Control Methods and Packaging test methods and Instrument manuals that must be used to test raw materials and components.

5.1.  Testing that requires the use of instruments

5.1.1.  The Technician needs to ensure that the instrument has been calibrated according to the calibration schedule.

5.1.2. If the instrument is within calibration, testing can proceed.  If the instrument has not been calibrated, the calibration must take place according to the appropriate SOP.

5.1.3.  If the instrument is out of calibration, alert the Laboratory manager so that the appropriate steps can be taken.  Do not use the instrument to perform the test.

5.2.  Packaging Material – Approval Against Supplier Certificate of Analysis or Conformance

5.2.1. For these approved packaging materials the Manufacturer’s Certificate of Analysis or Conformance is accepted as a basis for approval of the material in Production. The Certificate must clearly identify the respective delivery.  These packaging materials are identified as requiring Certificates of Analysis on the Packaging Material specification-Test Report.

5.2.2. If historically, a component has been accepted without testing and there have not been any major recurring complaints about the component, this component can continue to be accepted against the Certificate of Analysis or Conformance.  If problems occur with the component it is at the discretion of the Laboratory Manager to reinstate full testing of the material.

5.3.  Reagents used in testing

5.3.1.  Reagent solutions should be made up according to the Raw Material Specification-Test Report and Test methods.

5.3.2. When a reagent solution requires standardisation, this should be done in duplicate according to the compendia method, the duplicate results should not differ by more than 2%.

5.3.3.  The reagent solutions should be stored in appropriate containers (glass/plastic bottles) and labelled legibly with information as to name of reagent, strength and or factor, date of preparation or standardisation, storage conditions, expiry date, the initials of the person preparing the reagent and reference to the source of raw data.

5.3.4.  See SOP LAB-035 for information on the use and storage of analytical reagents.

5.4.  Standards used in testing

5.4.1.  When a standard solution has been made up accurately, the information regarding the standard should be recorded in the workbook.

5.4.2. The standard solutions should be stored in appropriate containers and labelled legibly with information including the name, date prepared, storage conditions, expiry date and the initials of the person who prepared the standard.

5.4.3. See SOP LAB-020 for information on the use and storage of Primary and Secondary Standards. Unlabelled chemicals are a safety hazard to others and does not comply to GLP.

5.5.  It is essential that work areas are clean and tidy at the end of the day.

5.6.  Equipment is to be left in a clean condition and ready for the next user.

6. Out-of-Specification Results

The procedure for dealing with Out of Specification (OOS) results is detailed in SOP LAB-055 using Form-310.

7. Microbiological Testing

Microbiological testing is required for various Raw Materials.

Check the Raw Material Specification and if “MICRO STATUS” is required, send the required sample to in house or contract micro laboratories. Document the micro results on to the Raw Material Specification-Test Report and on the trend card writing the contract laboratory reference no.

8. Completed Raw Material Specification Sheet

Completed Raw Material Specification sheets are placed in the “Raw Materials for Passing” tray for release by the Laboratory Manager or delegate.

9. Release of Raw Materials

9.1. The Laboratory Manager or delegate checks the completed Raw Material Specification and Test report against the standard Release Specification, workbook entries, proof of testings and the trend card (Form-265) before releasing the batch.

9.2.  The Laboratory Team Specialist or delegate assigns a RELEASE or CONDITIONAL RELEASE or REJECT status to the Raw Material.  The Raw Material Specification-Test report and the Trend card is signed and dated.

9.3. The Laboratory manager or delegate assigns an expiry date on the Raw Material Specification-Test report calculated by using the current Raw Material Specification.

9.4.  Once the usage decision has been made the material is released from Quarantine. Laboratory manager or delegate will sign appropriate number of RELEASED stickers one for each container kept in the warehouse QUARANTINE. The number of containers can be found from GRS slip.

9.5.  In case of non-conformance if a reject decision is made after an investigation, Laboratory manager has to complete the Deviation Report (see SOP LAB-055 and QMS-035) and issue appropriate number of REJECTED stickers, sign and send to warehouse.

9.6.  The Procurement Dept is alerted for reordering and/or credit for the rejected raw materials.

9.7.  The completed Raw Material Specification-Test report is filed in sequential order in appropriate filing cabinets.

9.8. Tested raw materials are disposed of in the “Security Reject Bin”.

10. Appendix 1 – Flowchart of Raw Materials through Laboratory

11. Summary of Changes