SAMPLE PROCEDURES

Bioindustrial Services is a contract laboratory specialising in the analysis of a range of products and raw materials for the Pharmaceutical, Veterinary Health, Cosmetics and Food and Additives industries.

SAMPLE PROCEDURES

The samples are delivered by the customer or via a courier delivery service.

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

All samples must have a Request for Sample analysis form completed and signed by the customer.

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

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

Please Note: All Samples delivered must be reconciled with the Request for Sample Analysis Forms. 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 the customer’s company and contact information. This is compulsory procedure.

The Receipt of Samples Book must be signed 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.

On receipt of samples, they are pre-sorted in the sample reception area as per the Request for Sample Analysis Form.

Each sample is allocated a Laboratory Information System (LIMS) generated laboratory number which is electronically captured onto LIMS. Details are recorded on a sample logging sheet, including date, customer, batch, analysis and release date to keep track of the analysis efficiencies. The numbering is sequential and reverts to one, on the first day of the month, 2020-A-0001.

Samples for stability storage and analysis are logged 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 are logged on to the computer, which notifies the laboratory administrator, who then notifies the laboratory supervisor, that the sample needs to be tested. A worksheet is completed, by the relevant laboratory and the sample is analysed.

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

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

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

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 worksheet are crossed out and signed, not erased.

All blanks are filled out with information, if not applicable, a ‘not applicable’ note is added. No dittos are allowed.

All forms, worksheets, and calibration forms must be completed with full information. No blanks or dittos are allowed.

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

Worksheets are signed by the analyst and senior analyst. Final reports are signed by the senior analyst and the laboratory supervisor.

Laboratory Information System (LIMS) logs and tracks the sample through a 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 onto the main frame computer which in turn is backed up onto two external hard drives each month.

Each hard drive is stored in two different locations.

During the annual shut-down of the laboratory, the hard drives are stored in a safe, offsite location.

Antivirus protection is enabled for the entire network.

LIMS is password protected and cannot be tampered with 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.

On completion of analysis, the calculations and calibrations are recorded on the worksheet.

The analyst and QA Supervisor signs and dates the worksheet, which is attached to all relevant graphs and chromatograms, where applicable.

The documentation is handed 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.

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.

The release date is recorded on the sample logging sheet, as well as on LIMS.

Monday-Thursday: 08:00 – 16:30
Friday: 08:00 – 16:30
Saturday: On Request
Sunday: Closed
Public Holidays: On Request