Initially validation batch of Oxcarbazepine Suspension, whole lot [REDACTION] was turned down on account of not Assembly viscosity specification, Though excipients utilized for the manufacture on the ton are all Assembly pre-decided specification
In the August 22, 2002 response, it states the methodology complies with the requirements of USP Sterility Exam [redacted] Validation for [redacted]. It clarified that the counts utilized to in the beginning inoculate the take a look at and Handle samples are quantified, however you don’t describe how the method is completed.
Procedures describing the calibration of devices and apparatus are deficiently published or followed.Â
b. Your firm’s qualifications on the Getinge Product 4300 autoclave and also the Grieve CLE-500 oven are inadequate in that you have not experienced this equipment with representative hundreds.
six. Completed solution plenty made from the validation batches weren't normally placed on Stability. The product or service and connected great deal figures representing validation batches that were not placed on steadiness include things like:
a. The calibration software on your stability chamber is deficient in which is doesn't include things like particular Instructions and schedules. You do not conduct re-qualification of The soundness chambers.
For each of your validation scientific tests, the First validation batch document has various handwritten annotations for system improvements which happen to be then transcribed around the batch data for the next validation batches. These system enhancements are also shown within the validation reviews. The amount of annotations over the Preliminary validation batch information as well as their character, which include [REDACTION] renders the initial operate a research and progress batch and demonstrates the batching process is not effectively proven on the outset of your validation research.
Your reaction implies that you've got prepared extensive protocols for accomplishing airflow sample screening to include all aseptic operations in keeping with sterile API production and hope to video history these exams.
Oven temperature for the tamper obvious seal around the neck in the bottle wasn't Element of the packaging validation and wasn't considered important to the procedure.
HEPA and ULPA filters take away sub-micron particles in the air, which happen to be way too smaller to discover but develop Large issues in lots of essential production functions. Examine filter capability and airflow resistance tests.
an anti-vibration mat, which performs the operate of isolating vibration among that which is earlier mentioned the mat and that that is below. Such a mat may possibly commonly be utilised when mounting a major device which vibrates, onto a concrete ground; during the absence on the anti-vibration mat, the device are likely to erode the floor by means of abrasion.
c. Style and design and Procedure in the [REDACTION] filtration unit situated in the Formulation location lets operator mistake to perhaps reverse the circulation of products under filtration.
Remember to involve with your response to this letter, a duplicate of the validation protocol specifying the amount of fluid for use [as you did for Cefepime (1g & 2g); Ceftazidime (1g, 2g, & 6g), and Cefazolin (500mg & 1g)], or demonstrate that the protocol refers to the laboratory method that was helpful at some time of your validation, indicating the quantity of fluid to utilize for reconstitution.
f. There isn't website a created method with the cleansing validation in the ribbon blender including the accountability for growth, functionality and approval on the validation examine.