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Saturday 7 November 2015

Basic pharmacy terms/definations part 7

Define Pharmaceutical Stating Materials, Intermediate , Bulk & Finished Products :

1. Define Stating Materials, Intermediate , Bulk & Finished Products :

Stating Materials : A starting material is known as raw material or an API. A substance is a defined quality which used in production of a pharmaceutical product & non-pharmaceutical product excluding packaging material.

Intermediate : A partly processed material that must undergo the further manufacturing steps before a bulk product.

Bulk Product : Any product that has completed all processing steps up to but not including final packaging.

Finished Products : A medicinal product, which has undergone all stages of manufacture including packaging.

Pharmaceutical Complaint, Recall, Corrective Action, Preventive Action, In-Process Control, Sanitation, Houskeeping & Self-inspection

1. Define complaint & recall.

All quality related complaints of a product from the market should be recorded & investigated accordingly to a written procedure.

Recall is the removal from the market of specified batches or all batches of a product. A recall situation can result from information entering a company in various ways:

• Customer complaints – these may be so serious as to initiate a

recall. An example could be the evidence of a lack of sterility

• GMP deviations/results of a failure investigation

• The result from the QC stability programme

• Request by the regulatory authorities

• Result of an inspection

• Known counterfeiting or tampering

• Adverse drug reaction (ADR) reported, leading to a recall decision (however, an ADR does not automatically lead to a recall).

2. Define Corrective Action & Preventive Action ?

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.

Differences between Sanitization and Sterilization? How to clean the Product Manufacturing Vessels?

1.How to sanitize the Water Supply lines?

Sanitize the water supply lines

Sanitize by Steam flush and Chlorinization.

2.How to clean the Product Manufacturing Vessels?

Wash the vat with portable water. Rubbing the vat & lid with 1% sodium lauryl sulphate & then washing the inner side & outside with potable water. Washing the vat by hot water & then rinsing the vat with DM water. Rubbing the vat with 70% IPA. And the cleaning procedure must be validated.

3.What are the differences between Sanitization and Sterilization?

Sterilization

Sterilization is a process or technique to remove bacteria and all types of viable microorganism.

Duration: 14 days

Sanitization

Reduction the number of micro-organism to a safe or relatively safe level as determined by applicable, regulations or the purpose of application

Clean Room & Aseptic Area, Air lock & Site Master File

1.What is Clean Room & Aseptic Area?

Clean Room

A room in which the concentration of airborne particles is controlled to meet specified airborne particulate cleanliness class. In addition, the concentration of microorganisms in the environment is monitored; is cleanliness class defined is also assigned a microbial level for air, surface, and personnel gear.

Aseptic Area

Any area in an aseptic process system for which airborne particulate and microorganism levels are controlled to specific levels appropriate to the activities conducted within that environment.

2.What is Air lock?

Airlock: An enclosed space with two or more doors, which is interposed between two or more rooms, e.g. of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to be entered. An airlock is designed for use either by people or for goods and/or equipment.

3.What Is Site Master File ?

Site Master File

Site Master File is prepared by the manufacturer and contains specific information about the quality assurance, the production and/ or quality control of pharmaceuticals manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceuticals operation is carried out on the site. A site master file need only describe those operations that is analysis packaging etc.

Sterilization, HVAC, Autoclave & DHS

1.What is sterilization? Mention the duration sterility test.

Sterilization is a process or technique to remove bacteria and all types of viable microorganism.

Duration: 14 days

2. Write the types of Sterilization.

Type of Sterilization:

Terminal Sterilization

1) Steam Heat sterilization

2) Dry Heat sterilization

Others sterilization

3) Gas sterilization

4) Sterilization by ionizing Radiation

5) Sterilizing by Filtration

6) Aseptic Processing

3.Write the functions & use of HVAC system.

Functions and use of HVAC

Write the full meaning of DOP & HEPA and its efficiency.

1.Write the full meaning of DOP & HEPA and its efficiency.

DOP : Dioctyl Phthalate .Dioctyl Pthanate test is used to determine the integrity of HEPA filters.

HEPA: High Efficiency Particulate Air Filter (HEPA) is a filtering system. HEPA filter capable of retaining 99.97 percent of particles as small as 0.3 mm. It is a disposable, extended media dry type filter in a rigid frame.

Efficiency: 99.97

Air classification of clean room, gram +Ve & gram –Ve bacteria & Endotoxin

1.Write short note on gram +Ve & gram –Ve bacteria ? which one is more pathogenic ?

Gram +Ve Bacteria

Gram +Ve bacteria are those that are stained dark blue or violate by gram staining. This is contrast to gram –Ve .

Gram –Ve Bacteria

Gram –Ve bacteria are those bacteria that do not retain crystal violate dye in the gram staining protocol.

Gram –Ve bacteria is more pathogenic than gram +Ve.

2.Write Air classification on cleanliness of parentral preparation.

Basic pharmacy terms/definations part 3

Empty Capsule Shell Weight & Capsule fill volume / weight capacity according to the density of the powder.

Dimensional Specification:

The following specifications apply to Capsugel hard gelatin capsules.

Weight:

The average capsule weight of an order is estimated by a representative sample average of 100 capsules falling within the limits given bellow:

(values in mg for one capsules)

Size	Target (mg)	Limits (mg)
000	163	150 – 176
00	122	112 – 132
0 el	112	103 – 121
0	96	86 – 105
1	77	69 – 85
2	62	56 – 68
3	49	44 – 54
4	39	36 – 44
5	27	24 - 36

A moisture content of 14% to 14.5% is assumed upper and lower limits are given at the 99.9% confidence level.

In empty hard gelatin capsule production wall thickness is carefully monitored and controlled by the regulation of gelatin solution viscosity. However, since the physical properties of raw gelatin are not constant. Solution density may vary and affect the resultant capsule weight. Therefore the above target weight should not be used as tare weights in capsule filling samples from the actual batch being filled should be taken as tare weights.

Capsule capacity:

The average capsule volume and filled capsule weight capacity for typical powder dose densities is as follows:

Capsule Size	Capsule Volume ML of Water	Capsule weight capacity in mg
		Powder dose density
		0.6 g/cc	0.8 g/cc	1.0 g/cc	1.2 g/cc
000	1.37	822	1096	1370	1644
00	0.95	520	760	950	1140
0 el	0.78	458	624	780	936
0	0.68	408	544	680	816
1	0.50	300	400	500	600
2	0.37	222	296	370	444
3	0.30	180	240	300	360
4	0.21	126	168	210	252
5	0.13	78	104	130	156

The above data are to be considered as approximations since filling product variables and filling machine type can significantly affect the capsule weight capacity.

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