What is the procedure for Sample Submission?

• The samples are delivered by the customer or through a courier service.

• Occasionally the samples are collected by laboratory personnel, at the request of a customer.

• All samples must have a completed and signed by the client.

• If samples are delivered by courier, the waybill is to be signed by the person receiving the samples.

is filled out by the customer and a quote is issued based on the sample type and quantity. The customer signs approving the analysis.

• Please Note: All Samples delivered must be reconciled with the . Any discrepancies must be sorted out prior to any signing of receipt.

• In case of a new customer, a Customer Information Form is filled out, detailing, that customer's company and contact information. This is compulsory.

• The Bioindustrial Receipt of Samples Book must be signed at all times by the courier or the Client, indicating that the samples have been delivered.

• There is no routine sampling conducted at the customer, unless it concerns a production problem that requires investigation.

What is the procedure for Sample Logging and Numbering?

• On receipt of samples they are presorted in the sample reception area as per the Request for Sample Analysis Form.

• Each sample is allocated a LIMS generated laboratory number, and electronically captured on the Laboratory Information System,(LIMS). The following details are recorded on a sample logging sheet, date, customer, batch, analysis and release date to keep track of the analysis efficiencies. The numbering is sequential and reverts back to one, on the first day of the month, 2015-A-0001

Stability Samples

Samples for stability storage and analysis are logged in with a sample number on the LIMS system and a schedule is worked out for the frequency and duration of stability. The sample is tested initially and a report is issued. Reminders for each cycle of testing is logged on to the computer, that notifies the laboratory administrator, who then notifies the laboratory supervisor, that the sample needs to be tested. A work sheet is completed, by the relevant laboratory and the sample is analysed.

What is the procedure for Distribution and Storage?

The sample is numbered and distributed to either the HPLC/Chemistry, Microbiology or Nutritional laboratory, where it is stored according to sample type i.e. either at 4 / 80C, refrigeration or at room temperature. Work flow is recorded on the white board in the main laboratory.

What is the Sample Turnaround Time?

Received samples have 5 working days in which the analysis has to be completed and the results released.

What is the procedure for Analysis?

All numbered samples are issued with a work sheet which is numbered and recorded and signed on issue.

What is the procedure for Document Control?

• Traceability of samples through documentation, means mapping the work done from logging to final report. This includes reference materials, instrumentation, environment, calculations, chromatograms/graphs and correspondence.

• All documentation is attached to the worksheet with the final report.

• Any changes to the work sheet are crossed out and signed, not tippexed.

• All blanks are filled out with information, if not applicable, a not applicable note is made. No dittos are allowed.

• All blank forms, worksheets, calibrations forms, are fully filled with all information. No blanks or dittos.

• Worksheets- All work done during analysis must be noted correctly and in detail. All instrumentation is stated by number and name, solutions and their concentration and all other relevant information involved in the analysis.

• Signing- Work sheets are signed by the analyst as well as the senior analyst. Final reports are signed by the senior analyst as well as the laboratory supervisor.

• Electronic Document control

Laboratory Information System(LIMS) logs and tracks the sample through an unique number, from analysis through to report and invoice.

• This unique number cannot be duplicated and used for a different sample.

• All electronic information from each networked computer workstation is backed up daily on to the main frame computer which in turn is backed up onto two external hard drives monthly.

• One hard drive is stored in the administration building and the other is stored in the laboratory.

• During laboratory yearly shut-down, the hard-drives are stored in a safe, off site.

• Anti –virus protection is enabled for the entire network.

• LIMS is password protected and cannot be tempered or reports altered.

• Only senior management is allowed access to certain pertinent sections of LIMS information. The Managing Director has complete access to all sections of LIMS.

What is the procedure for the Results?

• On completion of analysis, the calculations and calibrations are recorded on the work sheet.

• The analyst as well as the QA Supervisor signs and dates the work sheet which is attached to all relevant graphs and chromatograms, as applicable.

• The documentation is given to the Laboratory Administrator who completes the relevant Worksheet Registers.

• The Laboratory Administrator then enters all the relevant data onto LIMS, and generates a client report.

What is the procedure for Reporting?

• The final report is sent to the Managing Director for signature.

• The original report is faxed and filed for final posting to the client by the Laboratory Administrator.

• Release date recorded on sample logging sheet as well as the LIMS.