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Quality Control Capabilties

The Quality Control Laboratory function complies fully with cGMPs and is capable of performing virtually all testing in support of the product range.

Facilities consist of:

  • General laboratory with facilities for carrying out standard analytical operations such as titrations, solvent extractions, distillations, melting point determination, Karl Fischer automatic titrations, ash content, loss on drying, thin layer chromatography, etc.
  • Instrument rooms house gas and liquid chromatographs, headspace sampler gas chromatographs, UV/visible, IR and fluorescence spectrophotometers, thermogravimetric analysis equipment, an electronic polarimeter and a Malvern droplet and particle size analyser.
  • Balance room.
  • Laboratory offices
  • Storage room for retention of samples, glassware and laboratory equipment.
  • Wash-up area.

Approximately 60 chemical analysts, technicians and supervisory personnel comprise the staff of the Quality Control, Quality Assurance and Analytical Development functions.  Management recognises the importance of the skills inherent in graduates from tertiary learning institutions and employees who are not yet qualified at this level are encouraged to study towards this goal.

For convenience, the laboratory function is divided into the control of raw materials, in-process controls, and the control of finished goods.  Testing for verification of plant cleaning procedures also takes place in this area.

In addition to the above the Analytical Development Department has responsibility for method development and stability testing.

The services of a contract laboratory is used for the purposes of microbiological testing.  This external facility is audited to ensure compliance with GMPs.

In addition to qualifying internal reference standards, Fine Chemicals Corporation also supplies reference standard material for several products to the United States Pharmacopeia.

QUALITY ASSURANCE – frequently asked questions

  Topic Response
1 Is there a ‘Quality Manual’ that addresses the ‘Quality System’? Yes, in addition FCC has a comprehensive set of policies, procedures and working instructions that addresses cGMP requirements. The index for this system is available on request
2 Do you have an ISO 9000 certification? No – However the quality system addresses virtually all issues required by ISO 9000 and is more precisely targeted at cGMP as required by regulatory authorities
3 Is a documentation system of guidelines, regulations, and operation procedures available? Yes
4 How are documentation packages (master production and batch records) stored? How long are they retained? Hardcopy is stored for a minimum of 7 years in either a fireproof room or offsite in a controlled document warehouse.
5 Does quality assurance review the production records as part of the release criteria? Yes – Per SOP QA/14/P003
6 Are customer specifications available to Quality Control/Quality Assurance to assure that the requirements can be satisfied? Yes ;
7 Will you provide a Certificate of Analysis of each batch including actual analytical results. Yes
8 Would you notify the customer in writing prior to implementing major changes in acceptance criteria or manufacturing procedures? Yes
9 Do you perform cost/cause of failure analysis? Yes
10 Are failure investigation reports available? Yes
11 Is a self inspection programme in use with audits conducted by independent personnel? Are findings documented and does follow up take place to ensure corrective action? Yes
12 Are failure investigation reports reviewed by Quality Assurance? Yes
13 Do you perform annual reviews of products? Yes

 


Quality Control

The Quality Control Laboratory function complies fully with cGMPs and is capable of performing virtually all testing in support of the product range.... read more

Environment and Safety

FCC has in place appropriate Occupational Health, Safety and Environmental (OHSE) policies. The company employs a full time Risk / Loss Control Manager who...read more