Basic pharmacy terms/definations part 6

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.

 Documents : Documentation is a controlled written procedure, policy, forms or other pieces of paper as defines a company requirement. & describe how what to do.

Records :  When data or results providing evidence of activities performed then it is record.