6.3.2 Details within a product specification must not be altered without prior consent from the customer. All amendments must be signed and dated 6.3.3 All products must be manufactured according to the specification. Suspect or non-conforming raw material, part processed or finished products must be clearly identified as such, and dealt with accordingly e.g non-conforming raw materials are returned to supplier 6.4 Microbiological testing as appropriate 6. 4. 1 The microbiological testing regime and resource required, will ultimately depend on the nature of the product to be tested(e.g. degree of risk, shelf life and composition 6. 4.2 Where microbiological laboratory facilities are provided on site, they must be physically separated from production, and good laboratory practice must be evident 6.4 Microbiological testing as appropriate(Continued) 6.4.3 Adequate measures must be taken to ensure that the risk of cross contamination from laboratory areas to production is eliminated 1. Access must be restricted to"authorised personnel only il. Protective clothing worn in microbiological laboratories must not be worn in production areas li. Provision should be made for the safe storage and disposal of laboratory waste(both microbiological and chemical) in accordance with existing legislation lthough not recommended where microbiological testing of pathogens is undertaken, this must be segregated within the laboratory and strict precautions taken by staff to eliminate any possible threat to product v. Stringent precautions must be exercised when sampling to avoid any contamination risks which would result in an inaccurate test e. g use of contaminated glass, chemicals 6. 4. 4 Laboratory personnel must be competently trained to undertake the analysis, interpret the results and flag up problems when they arise Reference standards for microbial limits should be defined e.g absence of Salmonella in 25g, E coli <10 in 25g, Coliforms <100/g, TPC <100,000 CFUIg 6. 4.5 There must be daily communication between the microbiological laboratory and Quality Assurance department, through designated staff, to ensure that corrective action is taken in response to out of specification results 6. 4.6 It is recommended that In accordance with the appropriate hazards regulations, all laboratory methods adopted should be written up including an assessment of the hazard of each chemical used and relevant instructions to contain any hazard 6. 4.7 All laboratory equipment and instrumentation used should be clean, well maintained, serviced and calibrated at regular intervals, to ensure its accuracy, and this information kept on record 6.4.8 Where outside laboratories are used, whether for all or part of the microbiological testing regime(e. g pathogens)the premises should be vetted prior to commencement of the contract, to ensure that they too comply with points 6. 4. 1 to 6. 4.7 above Contract laboraties should therefore be assessed using 6.4.1 -6.4.76.3.2 Details within a product specification must not be altered without prior consent from the customer. All amendments must be signed and dated. 6.3.3 All products must be manufactured according to the specification. Suspect or non-conforming raw material, part processed or finished products must be clearly identified as such, and dealt with accordingly. e.g non-conforming raw materials are returned to supplier 6.4 Microbiological testing as appropriate 6.4.1 The microbiological testing regime and resource required, will ultimately depend on the nature of the product to be tested (e.g. degree of risk, shelf life and composition). 6.4.2 Where microbiological laboratory facilities are provided on site, they must be physically separated from production, and good laboratory practice must be evident. 6.4 Microbiological testing as appropriate (Continued) 6.4.3 Adequate measures must be taken to ensure that the risk of cross contamination from laboratory areas to production is eliminated:- i. Access must be restricted to “authorised” personnel only. ii. Protective clothing worn in microbiological laboratories must not be worn in production areas. iii. Provision should be made for the safe storage and disposal of laboratory waste (both microbiological and chemical) in accordance with exiisting legislation . iv. Although not recommended where microbiological testing of pathogens is undertaken,this must be segregated within the laboratory and strict precautions taken by staff to eliminate any possible threat to product. v. Stringent precautions must be exercised when sampling to avoid any contamination risks which would result in an inaccurate test e.g use of contaminated glass, chemicals 6.4.4 Laboratory personnel must be competently trained to undertake the analysis, interpret the results and flag up problems when they arise. Reference standards for microbial limits should be defined e.g absence of Salmonella in 25g, E. coli <10 in 25g, Coliforms <100/g, TPC <100,000 CFU/g 6.4.5 There must be daily communication between the microbiological laboratory and Quality Assurance department, through designated staff, to ensure that corrective action is taken in response to out of specification results. 6.4.6 It is recommended that In accordance with the appropriate hazards regulations, all laboratory methods adopted should be written up, including an assessment of the hazard of each chemical used and relevant instructions to contain any hazard. 6.4.7 All laboratory equipment and instrumentation used should be clean, well maintained, serviced and calibrated at regular intervals, to ensure its accuracy, and this information kept on record. 6.4.8 Where outside laboratories are used, whether for all or part of the microbiological testing regime (e.g. pathogens) the premises should be vetted prior to commencement of the contract, to ensure that they too comply with points 6.4.1 to 6.4.7 above. Contract laboraties should therefore be assessed using 6.4.1- 6.4.7 -