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Table 7.4 Information required for identification of R and T products by labelling

S. no. | Information

1 | Name of the product

2 | List of ingredients

3 | Net contents including weight, volume, etc.

4 | Batch number

5 | Expiry date

6 | Storage conditions or handling precautions, if necessary

7 | Directions for its use

8 | Warnings and precautions that are necessary

9 | Name and address of the manufacturer

10 | Any other information, if required as per the legislative guidelines

7.4.4 Hygiene and Sanitation

Sanitation and hygiene should be practiced during the manufacture of tropical root and tuber products. The broad aspect of sanitation and hygiene covers personnel, equipment and apparatus, premises, production materials, containers and anything that could become a source of contamination to the product. Large volumes of liquid wastes are created by washing roots and tubers, equipment and floors. The drainage should be discarded to avoid polluting rivers and conform to the laws of the environment.

The potential sources of contamination are to be minimized and eliminated through an integrated plan. The responsibility of sanitation should be assigned. The sanitation is to be carried out as per the written procedures and schedule. The equipment must be kept clean. The residues (fat or greasy film and protein) may protect microbes, even against the action of disinfectants. It then becomes very important to clean the residue from surfaces first, rather than directly going for disinfectants. A wide range of disinfectants are available, which may be single substances or mixtures. Some of the disinfectants are given in Table 7.5.

Table 7.5 Different disinfectants for premises for tropical roots and tubers

S.no. | Disinfectants | Effect on micro-organisms | Merits | Demerits

1 | Ethanol | Fair-Good | Evaporates rapidly • No residue is left • Quick action | • Flammable • Limited range of effect

2 | Iodine and iodophores | Good-Excellent | Effective in low concentration • Quick acting | • Sometimes corrosive • Stains some surfaces

3 | Chlorine compounds (like hypochlorites, chloroamines, etc.) | Good-Excellent | Broad range of effect | • Corrosive

4 | Quaternary ammonium | Fair-Good | Odorless • Limited effect compounds | • Some cleaning effect • Inactivated by soap detergents

Personnel Hygiene Policy GHPs (Good Hygiene Practices) deal with the necessary principles starting from primary production to the final consumer, ensuring safe food to the consumers. By adopting good preparatory methods, storage, packaging measures, the production of safe food is assured. The root and tuber processing plant should institute a suitable policy for personal hygiene. The following aspects are needed to be maintained:

• Employees should undergo health examinations routinely.

• Persons with diseases or other conditions that could contaminate food should not be allowed in the manufacturing operations. The other requirements may include cleanliness, clothing and removal of jewellery. The protective clothing should apply to all persons entering the manufacturing area.

• Personnel should be trained and a high level of personal hygiene should be observed.

• The hands repeatedly come into direct contact with the products, therefore need to be regarded as the first operational tool. If the hands are not subjected to strict hygiene, they may constitute the first vector of contamination.

• Signs to this effect should be posted and instructions observed within the food processing plant and a training programme be implemented to establish proper techniques for hand-washing and drying.

• Eating, smoking, drinking, chewing, and personal medicines should not be allowed in the production area.

7.4.5 Qualification and Validation

Qualification is an act of assuring that any premises or systems work correctly and lead to the expected results, whereas validation provides a high degree of assurance based on the documentary evidence about consistently function of the planned process. Validation is conducted in accordance with well-defined procedures and the results are recorded for future reference and verification.

The defined process, using the materials and equipment specified for tropical roots and tubers should be shown so as to obtain a consistent product of the required quality. Any change in equipment or materials, which may affect the reproducibility of the process and quality of the product, needs to be validated. Qualification and validation may establish and provide evidence that the system, inclusive of premises, equipment, supporting activities and processes, is designed as per the requirement of GMP.

7.4.6 Complaints

Written procedures and records must be in place for complaints about the product, investigations into quality defects and product recalls. All complaints should be registered and examined according to well-defined handling procedure. The subsequent action, if any, is to be recorded. The format for complaint reports can be adopted, as given in Table 7.6.

Table 7.6 Format for complaint report

S. no. | Criteria

1 | Receiving date of report

2 | Time of receiving report

3 | Complaint received by

4 | Complaint received from (person's name, address, contact number, email ID and fax number)

5 | Name, address, contact numbers organizations/persons

6 | Name of the Product

7 | Batch/lot numbers

8 | Name of complaint

9 | Details of products returned for examination

10 | Tell whether samples are available for collection/examination

11 | Findings of the investigation

12 | Conclusions

13 | Other decisive actions

14 | Details where letter is sent (also specify date)

15 | Whether product is required to recall or not

16 | Signature

17 | Date

(i) Review of complaints: Appropriately designated and trained personnel should review the complaints.

(ii) Records of complaints: The records should be retained and the trends may be evaluated to immediately take corrective actions.

(iii) Product recalls: A written procedure must be in place, which specifies the circumstances in which a recall of products should be considered. The recall procedure should specify who should be involved in evaluating the information, which may result in a recall, how a recall should be initiated, who should be informed about the recall, and how the recalled material should be treated. In the event of a serious and potentially life-threatening situation, local and national authorities should be informed and their advice sought.

7.4.7 Contract Production and Analysis

The roots and tubers industry has not been flourishing globally for the production of different products. Therefore, contract production appears to be limited in this field in the specific region. But the companies dealing with the product of global acceptance are increasingly considering the use of other manufacturers to produce their products.