ABSTRACT
It is the responsibility of all concerned department managers to follow the procedure. The manufacturing director, quality control director, and QA director are responsible for SOP compliance.
1. The manufacturing departments will be responsible for the following: 1.1 Scheduling of the validation runs 1.2 Raise media fill request form to all concerned departments with schedule (Attachment
No. I) 1.3 Provide operators involved in process simulation 1.4 Indicating responsible supervisory personnel 1.5 Perform media fill as per MFM and approved protocols 1.6 Provide the material and utilities to be used 1.7 Preparation of media 1.8 Clean the line after the run and prepare the area for real work 1.9 Review any major repairs 1.10 Review calibration status
2. The engineering and maintenance departments are responsible for the following: 2.1 Calibration of process equipment instrumentation on a regularly scheduled basis and/
or after repairs 2.2 Completion of major repairs/renovations prior to validation runs, if any 2.3 Provide historical data for temperature, humidity, pressure, and so on 2.4 Provide historical data for WFI and DI used during the media fill process 2.5 Participation and/or presence during media fill qualification
3. Quality control is responsible for the following: 3.1 Testing the microbial contamination and inspection of vials/ampoules 3.3 Water testing 3.7 CIP water (if applicable)
4. Quality assurance is responsible for 4.1 Process inspection/monitoring 4.2 Air monitoring for nonviable counts 4.3 In-process sampling (if required) 4.4 Batch documents review
6. The validation group is responsible for the following: 6.1 MFM initiation and review with the concerned departments 6.2 Protocols initiation and review with the concerned departments 6.3 Monitoring of completeness, accuracy, technical excellence, and applicability 6.4 Scheduling of the validation runs (in conjugation with the manufacturing
department) 6.5 Conducting of the validation runs including recording of all data, and so on 6.6 Data review and validation run acceptance 6.7 Final report preparation 6.8 Scheduled revalidation
7. Assistant manager QA, microbiological section head, QC director, sterile area production manager, operations manager, manufacturing director, and QA director will evaluate and approve the results in case of failure and determine the remedial actions.
