Filling
- Are sufficient personnel to supervise the assigned functions during filling?
- Are proper education and training records available?
- Are the HEPA filters supplied with sufficient air during filling process?
- Is appropriate airflow design present to facilitate segregated air systems for various aspects of processing like filling?
- Are necessary precautions taken to maintain aseptic conditions in filling process?
- Is the filling process validated by simulated media fill?
- Is the master file prepared for filling process defining validation, facilities and processes?
- In media fill tests is the frequency, criteria for qualification defined and are records maintained for the same?
- Are temperature and time limits established for the production phase’s completion?
- Is bioburden monitoring done before sterilization for raw, starting and in process materials?
- Are criteria for limits established in case of environmental monitoring and microbial physicochemical and endotoxins? Are effective measures taken when limits are exceeded?
Packaging materials
- Are the qualitative and quantitative requirements specified for primary and printed packaging materials?
- Are the standard operating procedures available for sampling, testing and receipt of packaging materials?
- Are the incoming materials stored in controlled areas till they are released from quarantine?
- Is the inventory maintained and are the released materials stored in controlled areas?
- Is every lot assigned with a reference or control number for control purpose and easy traceability?
- Is the label text approved by National Control Authority before using and is there a master file of approved labelling held by the responsible person?
Packaging & Labeling operations
- Are SOPs available for packaging & labelling for equipment and delivery of material to the floor and are they accessible to operators?
- Are packaging & labeling operations segregated to ensure there is no mixing of product or packaging materials?
- Is there any method to know the number of labels issued, used and returned to stock?
- Is the data on packaging batch records recorded?
- Is there any line of inspection before and after every packaging operation & labeling activity? Is it signed & documented by a responsible person?
- Is the name, batch number, strength displayed prominently at each operation?
- Is there sufficient on line control of packaged or labeled product along with printed text quality?
- Are the equipment pieces calibrated and certified when used before and after labeling operations?
- Are the limitations for temperature and time documented properly for packaging and labeling operations?
- Is there a proper record for the incidents, deviations and QA actions taken?
- Are the records maintained for the samples used for packaging materials and printed labels?
- Is there a quarantine area for finished goods which need to be released for quality control?
Packaging records
Each product, pack type and size should comply with authorized packaging. The packaging instructions are as following
- Product name
- Pack size should be expressed in terms of volume or weight of the product in final container
- List of all packaging materials required for a standard batch size with their quantities, types, sizes, and reference or code number specific to the packaging material
- Batch and expiry date of the product should be reproducible with printed packaging materials and specimens
- Precautions should be taken to examine the equipment and area before operations
- Description of packaging operation with the equipment and any subsidiary operation
- The details about in-process controls should be given for sampling and acceptance
- After packing and labeling reconciliation should be done.
- Line clearance records should be checked as part of batch packing records.
