Hello
Good day to you all.
This is my first post here. Please help me & take me to your good book.
Conventionally, IPQC is conducted at the beginning, middle and end of tablet compression. In this regard, what exactly does the end refer to? Some pharmaceutical companies used to perform the IPQC every two/two and a half hours. If the batch is small and completes within two hours, what should be the approach? I would appreciate it if you could clarify the matter according to guideline reference.
Generally, IPQC checks are performed during the entire compression run in case of tablets which cover the beginning, middle, and end including any breaks (regular breaks such as shift change over and sudden breaks due to stoppage of activity due to malfunctioning of machine, etc.) of the compression process. The frequency of conducting IPQC checks generally depends upon product and process knowledge gained during process optimization and validation studies. And also it is concerned with process variability and duration of compression operation.
Therefore, one has to decide which IPQC checks are to be performed more frequently and which checks are to be performed less frequently depending upon variability. Considering these aspects, IPQC checks may be done every 15 min, 30 min, 1 hr, 2 hrs, or at the beginning, middle, and end of operation.
For example Average weight, Weight variation of tablets can be checked more frequently than to check friability and hardness as long as compression force is kept constant throughout the operation. Similarly, physical dimensions of tablets, and appearance need not be checked too frequently as long as the lubricated granules are uniform with respect to the ratio of granules and fines. However, tablets disintegration test should be done more frequently covering tablets punched on all the dies on the compression machine. Generally, all the IPQC checks are performed at the beginning to ensure that tablet punched on every die on the compression machine meets the IPQC specification such as Appearance, Dimensions, Average weight, Hardness, Thickness, Friability, and Disintegration & Dissolution tests.
There are no specific regulatory guidelines for determining IPQC check frequencies.
Thanks.
If a stable product has a total tablet compression time of 40 hours, and if the IPC team performs IPQC (Hardness, DT & Friability) once at the beginning, again at 16 hours and finally at 32 hours; However, checking of the control weight, weight variation, room conditions and appearance of the tablets are performed in every hour.
Then, could the company face any regulatory scrutiny? Or, could any auditor raise question mark on this practice?
Thanks in advance.
As I explained in my previous communication, no specific frequencies are defined for conducting IPQC checks. It all depends upon the product and process confidence developed during its optimization, validation, and the type of compression machine used.
For any new product, IPQC checks are generally performed more frequently to generate sufficient data and confidence to determine whether the process is under control. Once it is established, IPQC frequencies can be reduced with supporting data from previous batches. Considering the length of time of compression, it appears that you are using a single rotary compression machine (instead of a double rotary compression machine) with a limited number of punching stations. Please take a rational decision about IPQC frequencies based on previous data as well APQR (Annual Product Quality Review data) of this product.
Therefore, your R&D, production & QA has to decide about IPQC frequencies rationally.