What are the basic requirements of premises of pharmaceuticals production Area, product & RM Storage Area?

1.What are the basic requirements of premises of pharmaceuticals production Area?  

Premises of Manufacturing Area

1.Dedicated facilities

2.Logical flows of materials and people.

3.Adequacy of working space and orderly and logical positioning of equipment.

4.Interior surfaces smooth, crack-free and easy to clean.

2.What are the basic requirements of premises of pharmaceuticals product & RM Storage Area?  

Premises of RM store Area

1.Storage areas of sufficient capacity

2.Clean, dry and maintained within acceptable temperature limit

3.QC sampling area with GMP standard

4.Segregated areas for rejected recalled and returned materials

5.Separate areas for highly active hazardous narcotics materials

Premises of Manufacturing Area

5.Dedicated facilities

6.Logical flows of materials and people.

7.Adequacy of working space and orderly and logical positioning of equipment.

8.Interior surfaces smooth, crack-free and easy to clean.

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.

Air Classification on cleanliness of parentral preparation

Grade            At Rest                       In Operation        

              Maximum permitted particles/ m3 = or above

               0.5 µ        5µ                0.5µ             5µ

Grade A  3500         0                 3500            0

Grade B  3500         0                 350000        2000

Grade C  350000    2000            3500000      20000

Grade D  3500000  20000              Not Defined

3.Mention Autoclave period and temperature.

Temperature : 121^{0 C}

Duration : 15 minutes

Pressure : 15 lbs Pressure/Square inch

4.What is the source of Endotoxin ? Write the source of Microbial Contamination of Product.

 

Endotoxin are bacterial dead cell or garbage.

 

Source of Endotoxin

Gram –Ve bacterial cell wall.

Source of microbial contamination of a product

Person, Water, Air, RM, Rubber stopper, Glass Vial and Garments

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

Heating, Ventilating and Air conditioning system is used for temperature and humidity control with in a manufacturing environment. It includes air handling units, air distribution network, air-cooling and heating system, air filtration, equipment control system, monitoring and alarm decreases

4.Write the conditions of sterilization by Autoclave & DHS.

Condition of sterilization by Autoclave & DHS

121 ⁰ C 15 lbs pressure per square inch 15 minutes

200 ^o C for 1 Hour.

21. What are the points to be checked during validation of DHS/ Autoclave?

Points to be checked during validation of DHS/Autoclave

Checked by biological indicator (Bacillus sublitis) and endotoxin indicator for DHS

Checked by biological indicator (Bacillus stearothermophilus).

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