PQ for Syringe/Vial Filling Machine

GOOD DOCUMENTATION PRACTICE (GDocP) PQ (PERFORMANCE QUALIFICATION)
1

Dear Forum
Need your expertise to guide me what the tests shall PQ for syringe or Vial filling be included other than the routine media fill?

Best Regards

M. Musbah

2

PQ vial filling have these sections

VALIDATION TEAM AND RESPONSIBILITIES (Engg, QC, QA, Production)

PERFORMANCE EXPERIMENTAL PLAN (System Description, Performance Test plan, Summary of Validation studies)

PREREQUISITES (Test equipment Calibration Verification, Sop Verification)

PERFORMANCE EXPERIMENTAL PROCEDURE (Filled Volume, Extractable volume,Pre & Post Nitrogen, Optical Inspection–You must specify limits)

ACCEPTANCE CRITERIA

REFERENCE

REVALIDATION CRITERIA

LIST OF ANNEXES (Specific gravity, Inprocess check sheet,Satistical quality control charts,Test equipment calibration verification,Report log book and Report form)

REVISION HISTORY

3

Hi Musbah,

Thanks for sharing the information
I think that would also apply to other filling machines.

Many thanks,
Mary

4

A PQ shouldn’t be necessary given your testing in the OQ is adequate. Media fills will essentially be your PQ.

5

Mr. Spencer,
I do not know the geographical region you represent.
Most of the regulatory authorities these days are keen to know 2 important points in the manufacture of a particular sterile dosage form

  1. What is the shortest time to complete a batch?
    2.What is the shortest time to fill and seal a batch?

Question no 2 talks about various issues which normally everyone ignores.

What is the time taken to fit the Volumetric dispensers or filling sets?
What is the time taken to set correct volume?
What is the time taken to align the line?
What is the time and speed taken to fill and bung the machine?
What is the time taken to seal all the filled+bunged(Stoppered) vials or Filled ampoules to seal on a vial or ampoule filling machine?
What is the exact time taken for such interventions?

PQ should be done based on these interventions, capacities operated, controls that filling machines have and maintaining required controls of environments during such manipulations and filling operations.

Everything is connected to quality here.
If we do not know any previous knowledge about these parameters,Media fills will become a night mare and it will be full of deviations with interventions.

PQ is very essential and it should be done with a risk based methodology.

We at Kneat Solution have a software that makes all the validation parameters counted in risk based methodology.
Iam not adevertising here about our products here in this scientific forum.
Iam letting you know how important to consider various operations.

For example for certain biological products which foam or highly viscous-- Vibration is extremly important parameter. Vibrations on conveyer and from machines must be controlled to as low as possible. The reason is it causes foaming and denatures Biological products durung Fill and Finish operations.
If you are new I request you to kindly look our article on Fill finish considerations for Biologicals.

Regards