QAS-004 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 213

SOP No. QAS-004.00 Effective date: mm/dd/yyyy
Approved by:
23.3.4 S amPling of i injectaBleS
At the completion of bulk manufacturing, the QAI will be informed by the production operator to
collect the samples for microbiological test. The QAI will collect the samples in sterile pyrogen-free
bottles for microbiological tests and in clean amber glass bottles for chemical analyses. The QAI
will then label the bottles appropriately with the product's name, batch/lot number, and code num-
ber and will send them to the QC laboratory along with bulk release form (Attachment II). The QAI
will register the samples in the bulk sampling register of QA.
23.3.5 f or S terility t eSting
In order to represent the entire batch and processing conditions, samples should be taken
• At the beginning, middle, and end of the aseptic processing operations
• In conjunction with processing interventions or excursions
Processing excursions or interventions could be but not limited to the following:
Excursions to the time limits (durations) of
• The period between the start of the bulk product compounding and its sterilization
• Filtration processes
• Product exposure while on the processing line
• Storage of the sterilized equipment, containers, and closure
Interventions that occur :
• Maintenance
• Stoppages
• Equipment adjustments
The sample for the sterility test will be divided over the filling process plus samples in conjunction
with the intervention and excursion. The QAI will document the sampling time and reasons on the
control chart and will mark the ampoules to correlate accordingly.
23.3.6 S emifiniShed S amPling for c hemical
The samples after terminal sterilization, or cold leak test of the ampoules after capping of vials, are
collected in a polybag. The polybag should be labeled appropriately with the product's name, batch/
lot number, and code number. The area QAI will send the samples along with the bulk release form.
23.3.7 f or l iQuid -B orne P articulate m atter
Sampling for liquid-borne particulate matter is carried out after visual inspection. Samples are
collected in a labeled polybag. The QAI will make entries in a sampling register of QA and will send
the samples to QC with the bulk release form (Attachment III).
23.3.8 r eSamPling r eQueSt in c aSe of r ePeat t eSting
The request will come through production along with “sampling advice” mentioning the reason for
resampling, for example, whether a cumulative sample or individual container samples are required.