Useful questionnaire for pharmaceutical manufacturers for compliance of Good Manufacturing Practice Regulations (GMPs), Title 21, CFR Parts 210 and 211 for sterile dosage form production
There are instances where the final product meets all the criteria and it is found that there is violation of good manufacturing practices then inspecting regulatory authorities ask for immediate compliance if it can be done there and there, many times avoid actions, which doesn’t mean that the actions always are not taken in such instances the method is used to facilitate improvements, while the action are also taken in such instances.
If you are preparing for FDA inspection or any of facility audits by any regulatory agency in any part of world, here is an useful questionnaire which regulatory agency is always interested to find out the answers of which, while inspection of sterile dosage form producing firm.
Aseptic Sterilization Systems
Dry Powder Filling
1.Briefly describe the processes used for preparing the sterile drug powder (i.e., sterile filtration, crystallization, spray drying, EtO gassing, etc.
2.Is the production facility dedicated to the product? If not, determine the potential for cross contamination with other products manufactured by the firm.
3.Are any penicillin products produced in the same facility as no penicillin products?
4.Briefly describe the environmental monitoring performed by the firm in critical areas during actual production. (e.g., how are Class 100 conditions maintained? Where are the sampling sites?
Is non-viable particulate monitoring performed?
5.Review monitoring data for several representative months of production. Were results within specifications? If not, what was the firm's response? How many months were reviewed?
6.Does the firm have written procedures describing the filling of sterile dry powders?
Dry Fill Validation
7.How has the firm validated the filling operation for product homogeneity?
8.Is the sterile filling procedure validated by media fill procedure, placebo fill procedure, or other (describe)?
9.Briefly describe media fill procedures or placebo fill procedure (including frequency; whether performed as its own batch or piggy-backed onto a production batch; number of vials routinely filled; etc.).
10.Review results of medial fills/placebo fills performed since last EI (or a minimum of 3 runs, whichever is greater). Are results within specifications? How many fills were reviewed?
11.What are the firm’s specifications and procedures following an out-of-limit media fill/placebo fill result?
1.What placebo material is used?
2.How is the placebo material sterilized?
3.Does the firm utilize the same acceptance criteria for placebo fills as for media fills? If not, and higher alert and action levels are permitted for the placebo fills, determine rationale.
4.How long and at what temperature(s) are placebo filled units incubated?
1.Has the firm or an outside supplier performed physical and chemical challenge testing of each filter and product combination in the manufacturing process to validate filter-product
compatibility? (If these tests were performed by an outside firm, report the name and address).
2.Summarize study results or attach documentation.
3.Did the test conditions duplicate, as nearly as possible, the actual conditions of production?
4.Following validation of a specific filter for a given process and product, does the firm extrapolate the validation findings to related products having similar attributes and processing
conditions? If so, is the justification for such extrapolation documented? Is filter performance data correlated with filter integrity testing data as part of the justification?
1. is a "worst case" organism used?
2. do challenge tests cover:
1. flow conditions, pressures, volumes
2. fluid characteristics, including pH, ionic strength, surface tension. Is there a limit of centipoise for solutions to be filtered. Has the firm determined the effect of elevated viscosity over extended time periods, if applicable? Adv how to make money on internet
3. time, Does validation cover "worst case" conditions?
For example, the firm is doing a continuous form/fill/seal operation and using the filter over an
extended period of time.
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