In Stability Testing - Overview, we look at Stability Testing Requirements - Chamber Selection, Validation Requirements, IQOQPQ and IPV Issues.

As a way to show your drug's shelf life in multiple markets, the manufacturer must retail it for any specified period of time in relation to temperature and humidity. This is done in a stability lab (also known as a stability drawer).

Regulators in each market, including FDA in the US, HPRA in Ireland, specify the temperature and humidity conditions that should apply and the storage time of test samples, such as a minimum of 6 to 12 months. During this period, test samples were evaluated and their potency and degradation were assessed and captured. This is called a stability test.

The most common conditions are 25°C/60%RH. For the first project, the added condition may be 40°C/75%RH. Other conditions include 30°C/65%RH, 30°C/35%RH and 25°C/40%RH.

Another problem is that the temperature of the items to be stored in the refrigerator is 5°C ±3°C. Test conditions are -20°C ±5°C for items intended to be stored in the refrigerator.

Intangible Cultural Heritage

ICH is the International Conference on Harmonization of Technical Requirements for Therapeutic Products for Human Use, which develops regulations for job stability testing. ICH Q1A states that conditions must be maintained at ±2°C and ±5%RH at regular intervals during stability testing.

Also, if these conditions are definitely not met for more than 24 hours, the test may have to be extended, resulting in multiple modalities. Reports are required if conditions deviate from ±2°C/±5%RH for a short period of time. This may be due to the front door opening to "paint" the example. This type of activity is usually recorded in the room sign.

If you cannot find an obvious explanation, you may need to seek help from a service specialist. If there is a problem with the chamber of commerce, a simple answer is required from the reseller, and although he is expected to provide a lot of additional content, the auditor also expects some content from the web page. It is also recommended to get redundancy, i.e. have another room on site as a backup of files. The Stability test chamber must be fully validated and ready for use.

Photostability Test Chamber

To demonstrate shelf life under ambient light conditions, test samples can be exposed to precise doses of UV light and visible light in specially designed compartments. ICH Q1B states that the temperature must be controlled to prevent local very hot locations.

Safety and 21 CFR Components 11

Indoor conditions must be independently monitored. This usually requires temperature and humidity transmitters connected to the recording method. At light stable room temperature, it is likely that UV light and significantly high-intensity light will be captured.

The device must comply with US 21 CFR Component 11 rules, whether it is a paper recorder or a computer. 21 CFR Component 11 states that most relevant detail classification and storage systems must be designed to prevent counterfeiting, damage, untraceable alterations, or damage to detail. For laptops or computer systems, routine tests (IQOQ - Setup Qualification, Operational Qualification) must be performed to show compliance.

Chamber of Commerce Qualification

Likewise, routine testing of your new chamber (IQOQ and PQ performance certification) is required. During its lifetime, it should be kept regularly (usually an annual preventive maintenance support and calibration evaluation), preferably with multiple probes mapped annually (IPV - Instrument Performance Verification).

PQ and IPV typically require at least a 24-hour track operation, unloading, packing, or both. During this operation, the screen conditions must remain at the set point ±2°C, ±5%RH. Inspection equipment for these specific assessments must be retroactively adjusted at least annually and meet the IQOQ general criteria of 21 CFR P11.

Stability Chamber Selection Questions

The following factors need to be considered:

Reliability Is it recognized, applied and reliable?

Should reduce temperature and humidity imbalances

Prepare for potential and existing needs

Footprint footprint is probably the smallest

Do you offer neighborhood support for quick response, spare parts inventory and certification for refrigeration repairs?

Chambers should include handles such as temperature limiters and error meaning records

It has to be refilled quickly.

Reduce user service

Few consumables required

Produces clean and sterile moisture. Microorganisms must not be injected into the chamber

It should be possible to lock the keyboard

Errors should have results, which can be monitored through development management methods

Excellent automated production training should be developed according to GAMP

IQOQ, PM and IPV have traceable calibration, are 21 CFR Component 11 certified and should be obtained from Stability Chamber Manufacturer Thchamber.