What are critical, major and minor defects of a product ?
1.What are critical, major and minor defects of a product ?
Critical defect : Critical defect are those defect which can be life-threating & which require the company to take immediate action by all responsible means as soon as the defect becomes apart whether in or out of business hours.
Example : 1. Products labeled with incorrect name.
2. Counterfeit or deliberately tampered with product/
3. Microbiological contamination of a sterile product
Major defect : Major defect are those defects which may put the patient at some risk but. Which are not life-threating
Example : 1. Any labeling/leaflet misinformation which represents a significant hazard to the patient
2. Microbial contamination of non-sterile product with some risks.
Minor defect: Minor defect are those defects which present only a minor risk to the patient. Any batch recall or product withdrawal would normally be initiated a few days.
Example: 1. Readily visible isolated packing faults
2. Contamination which may cause spoilage or dirt & where there is minimal risk to the patient
What is SOP?
1.What is SOP? Why it is needed ?
SOP (Standard Operating Procedure)
A written approved procedure which gives instruction for performing operation not necessarily specific to a given product or material but of a more general matter (e.g. equipment operation, maintenance and cleaning of premises, and environmental and sampling and inspection).
Purposes: To describe the method for writing procedures for all general operations.
2.When and where revalidation 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.
What is pharmaceutical sampling, documents & records?
1. What is sampling? What standards are used for sampling?
Sampling: The taken of samples or sample, which represent the whole batch or lot.
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 are inspected & determined the acceptability the lot or batch. Military Standard 105E is frequently used for determining statistical sample size.
2. Write the differences between documents & records.
