Challenge Test

Challenge Test: 

The filter is the ability of a filter to retain microorganisms involving filtration 

of standardized culture containing a large number of small microorganisms.

Negative Controls

Negative Controls: 

Negative controls are the culture media without addition of product sample or microbial challenge. 

The –ve control as used to velocity the sterility of the medium before during and after the incubation 

period of the sterility tests.

Positive Controls

 Positive Controls: 

The medium used for sterilization’s cheeked for its efficacy, to support growth of different organism by adding 10-100 cfu of m gm. This is known as positive control.

DOP Test (Dioctyl Pthanate Test)

DOP Test (Dioctyl Pthanate):  

   

        DOP Test: Dioctyl Pthanate test is used to test the HEPA filters for leaks. The DOP aerosols of 0.28 mms – 0.4 mms size are introduced upstream of the filter and leaks are detected down stream with an aerosol photometer.

Accuracy in Pharmaceuticals

Accuracy:

     Accuracy defines the agreement between the true value and the value found in the testing. The closeness of the result obtained during measurement or analysis to the true value. Bias is a systematic deviation from the true value. It normally refers to the difference between the mean of the set of results of analysis of the unknown are compared with the results obtained from the analysis of standards or reference materials. Accuracy expresses closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found. Accuracy can be determined by comparing the results with those obtained using an alternative method which has already been validated. Accuracy may be determined by applying the procedure to samples of the material to be examined that have been prepared with quantitative accuracy. For analytical methods there are two possible ways of determining the accuracy; the so- called absolute method and the comparative method.

Strength in phamaceuticals

  Strength: 

     Strength means the concentration of the drug substances (for e.g. weight/ weight, weight / volume or unit dose and or the potency of a drug product). A quantitative measure of active ingredient as well as other ingredients requiring quantitation such as alcohol and preservatives.

Revalidation in Pharmaceuticals

When and where re-validation is required?

Revalidation means that the original validation program should be repeated at a predetermined frequency. This work is carried out 3 years interval & any change of critical steps or process.

i.             Changes in raw materials (Physical parameters such as viscosity, density, moisture & Particle size distribution) may affect the products & process

ii.            Changes in the sources of active raw materials manufacturer

iii.            Changes in the packaging materials (Primary packaging/Closure system)

iv.            Changes in the processes (e.g. mixing time, dry time, drying temp.& batch size)

v.            Changes in the equipment (e.g. addition of automatic electric system)

vi.            Changes in the plant or facility

vii.            Variation revealed by trend analysis.

Sampling in Pharmaceuticals

What is sampling? What standards are used for sampling?

Sampling should be conducted according to written procedures. Sampling Process are obtain from finished material, in-process material, raw material or components for assessment with a view to determining the properties of the universe from which they were drawn.

Sampling plan -

Specific design indicating number from each lot or batch is inspected & determined the acceptability the lot or batch. Military Standard 105E is frequently used for determining statistical sample size.