A comprehensive cleaning SOP divided into (i) Type-A (ii) Type-B (iii) Type-C cleaning regarding processing zones is in place, in addition cleaning SOPs concerning production corridor area, equipment area, and other areas have also been standing out under the SOPs in greater details. The responsibility of the senior concerned officials and other staff members who have been assigned with the cleaning exercise have also been laid down in the SOPs. The details of equipment, consumables, and other cleaning aids as per international standards are regularly provided. It is ensured that sufficient stocks of such consumables and cleaning aids are available wherever required the cleaning of equipment and other delegate accessories is carried out by using RO Water.
Detailed SOPs for cleaning validation have also been prepared on international standards. Properly segregated responsibilities have been assigned to the production department, QA department, and QC department to validate and ensure that all the required actions as per SOPs are duly complied with. It is also ensured that during the validation process, the material required for sampling and the activity of a selection of product and equipment for the conduction of cleaning validation is carried out effectively, including the selection of the possible worst case requiring the cleaning validation.
Detailed and effective cleaning validation protocols are also in place which includes study design, documents to be checked, list of documents, list of equipments, tests to be performed, sampling plan, calculation of residual contamination, deviation report and over all summary of the validation process, a periodical report is issued by the Assistant Manager QA with the approval of Manager QA. The complete SOPs for all cleaning areas are available in the respective file of QA department.