Quality Control and Testing

Quality control programme shall be in place to include inspection and testing of incoming raw materials and finished products.

Laboratory facility and trained and competent testing personnel shall be available for food testing. If there is no in-house laboratory present, all the regular testing done through an accredited external laboratory/laboratory shall be notified by FSSAI. In case of complaints or feedback on the product, the FBO shall carry out the testing either though their in-house/ external accredited labs/ lab notified by FSSAI to ensure product compliance to standards.

Incoming raw materials / Bulk chemicals / Ingredients test records or COA shall be maintained.

If pathogen testing is conducted in-house, microbiology laboratory shall not be open directly into process area. Tested sample and remnant shall be autoclaved before disposing off.

Calibration of laboratory equipment shall be done periodically.

Specification and Test Methods:

Authorized specifications for raw material, packaging materials, In-process material, Intermediate material, and finished products should be maintained. The specifications should include;

• A description of the materials,
• The designated name of the material / product and the code reference
• Directions for sampling and testing
• Qualitative and quantitative requirements with acceptance limits
• Storage conditions and any special handling precautions
• Shelf-life

NOTE: Adequate gradation of the surrounding area shall be designed to maintain the integrity of the targeted class.

Validated methods should be used for testing of material / product. Analytical method verification should be carried out for the compendia / pharmacopeia methods. Scientifically valid test methods published internationally (e.g., AOAC, BAM, USP, FCC etc.) can also be used for testing and the manufacturer should affirm that the tests are accurate, precise and specific for its intended purpose.

Laboratory Personnel:

• Personnel shall be appropriate in number with desired skill set.
• All personnel shall wear clean protective clothing appropriate to the tasks being carried out.?

Laboratory Facility and Equipment:

• All laboratory equipment and instrumentation shall be appropriate for the analysis required and shall be calibrated. Written operating procedures shall be available for each instrument or equipment.
• Quality Control laboratories should be designed and equipped to suit the operations required.
• Sufficient space should be available for storage of chemicals, media, glassware, documents, samples and records,
• Personnel operating the equipment shall be trained.
• Records of each service and calibration must be maintained for each equipment,
• Adequate waste bins shall be provided for the collection of laboratory waste material prior to disposal.
• Analytical methods shall include a control step to verify instrument or piece of equipment is functioning accurately.

Sampling:

• Sampling procedures shall be established and documented.
• The following shall be included as a part of sampling procedure
• The sampling equipment and type of sample container to be used
• The method and frequency of sampling
• Sample storage and handling requirements prior to testing, e.g., to minimise separation of mixed powders
• The quantity of sample required
• Any special precautions to be taken to maintain homogeneity of sample
• Instructions for any subdivision of the sample
• The cleaning and storage of sampling equipment and reusable containers
• Sample containers shall be clearly labelled with the contents, sample identification number, lot number and date sampled.
• Tables or notes used for calculation of the sample requirements shall be documented.

Analysis:

Written procedures shall be in place for the preparation of the reagents to be used in the analysis.

Reagents and Reference standards shall be clearly labelled with the following information:

• date of receipt or preparation,
• their concentration,
• standardisation factor,
• shelf life
• storage conditions

Reference standards and any secondary standards prepared from them should be stored, handled and used according to instructions.

Validation shall include the following parameters

• Specificity / selectivity;
• Recovery;
• Precision;
• Linearity and range;
• Accuracy;
• Limit of Detection (LOD) / Limit of Quantitation (LOQ)

Validation details shall be recorded and retained. Results of any sample analysis should be within the validated range of the methods used

Samples shall be analysed according to written procedures, using test methods which are either legally required or are internationally accepted, or other methods that have been scientifically validated for the required sample matrix.

Laboratory Documentation:

• Procedures shall be in place so that the data for all sampling, analysis and calculations are correctly recorded.
• Records duly signed off shall be maintained for all tests and analysis performed in the laboratory.
• Retention of laboratory documents, records and retained samples shall be done for a time period that is consistent with the requirements for the manufacturing records.

Control of Retention Samples:

• Retention samples of key raw materials and finished products should be stored in appropriate conditions and quantity.
• Retention samples of finished products shall be stored in the same or simulated containers as per shelf life in which the finished products has been actually marketed.

External Laboratory:

• There shall be clear defined scope, details of services and responsibilities with contracted external Laboratory.
• External laboratories shall be nationally/ internationally accredited.
• Trend analysis shall be carried out periodically on all analysis carried out by external laboratories, to ensure that there are no major trends or variations developing.