Sunday, June 30, 2013

Free Download of Formulation Technology by H. Mollet; A. Grubbermann. Emulsion, Suspension & Solid Dosage Forms.

Free Download of Formulation Technology by H. Mollet; A. Grubbermann. Emulsion, Suspension & Solid Dosage Forms. This Book deals with the formulation & pharmaceutics of emulsion, suspension and Solid dosage forms. To download this book please click on the image or link below:

 Size: 30 MB

Monday, June 17, 2013

What is training ? What are the functions of Qualified and key personnel in a Pharmaceutical Industry ?

1.What is training ? Why it is needed ?

Training: Training is a tool/way to know something to increase our knowledge or skill.

Importance of training:

Training helps to provide an opportunity and broad structure for the development of human resources technical and behavioral skills in an organization. It also helps the employees in attaining personal growth.

2.What are the functions of Qualified and key personnel in a Pharmaceutical Industry ?
              I.A qualified person must ensure that each batch has been produced & tested/ checked in accordance with the directives & marketing authorization
           II.A qualified Person musr certify in a register or equivalent document as operations are carried out & before any release that each production batch satisfies under the requirement of GMP

Functions of key personnel in a Pharmaceutical Industry:
              I.To ensure that the production records are evaluated and signed be an authorized person before they are sent to the QC department.
           II.To check the maintenance of his department, premises and equipment.
         III.To ensure that the appropriate validations are done.
        IV.To approve or reject, as sees fit, starting materials, packaging materials. And intermediate, bulk & finished products.
           V.To evaluate batch records.
        VI.To ensure that all necessary testing is carried out
      VII.To approve specifications, sampling instructions, test methods and Quality Control procedures.
   VIII.To approve and monitor any contract analysis.

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                       0.5µ            
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 : 1210 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 is a process or technique to remove bacteria and all types of viable microorganism.
Duration: 14 days
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

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.

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 ?

Preventive Action : In order to prevent occurrence the potential action has to be taken from non         conformity, defect or other undesirable situation.

Corrective Action :  Action has to be taken to eliminate the detected non conformity or other undesirable situation.

3.      What is In Process Control  ? Why it is important ? 
To ensure the product conformation of its specification, checking & monitoring are performed during production. The controlled of the environment or equipment may also be regarded as part of in process controlled.

Importance : It is important to adjust the process to assure that the product confirms to it final specification.

4.      What is Sanitation & House keeping?

Sanitation : It is the hygienic control on manufacturing process including personnel, premises, equipment & material handling.
Housekeeping is the practice of keeping the workplace clean, tidy & free of potential hazards. Correct housekeeping is practised before, during & after the task is completed.

5.      What is self inspection?

Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.

What is validation? What is the importance of validation in pharmaceutical industry?

1.      What is validation? What is the importance of validation in pharmaceutical industry?
Validation is a documented evidence which provides a high degree of assurance that a specific process, method or system will consistently produce to the required specification in accordance with accepted standards of cGMP.
Importance of Validation :
a)In pharmaceutical industry the validation is required for national or international regulations
b) Validation is a part of integrated requirements of a quality system
          c) Validation meets the consistency of quality product in all stages

2.      What do you mean by Prospective, Retrospective and Concurrent validation?

Prospective  : A prospective process validation states that three consecutive marketed batches are manufactured & tested as per prospective process validation SOP. Validation data has generated by validation committee. When all data are fully satisfied then this product are released for sale & called this process is validated to use routinely in production.

Retrospective : A retrospective process validation are performed by documenting all the historical information of existing 10 products using trend analysis data in QCMS system & its ensures that the existing process is under control.

Concurrent validation : Concurrent validation is carried out during routine production. This method is effective only if the development stages have resulted in a proper understanding of the fundamental of the process. Some manufacture refers the concurrent validation as Prospective process validation.

3.      Write the basic requirements of cGMP/GLP?
Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorization or product specification.
Good Manufacturing Practice is concerned with both production and quality control. The basic requirements of GMP are that -
a. appropriately qualified and trained personnel;
b. adequate premises and space;
c. suitable equipment and services;
d. correct materials, containers and labels;
e. approved procedures and instructions;
f. suitable storage and transport;

4.      What do you mean by DQ, IQ, OQ, &  PQ ?
Design Qualification (DQ): documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose.

Installation Qualification (IQ): documented verification that the equipment or systems are installed or modified &  comply with the approved design of the manufacturer’s recommendations and/or user requirements.

Operational Qualification (OQ): documented verification that the equipment or systems are installed or modified & perform as intended throughout the anticipated operating ranges.

Performance Qualification (PQ): documented verification that the equipment and ancillary systems are connected & can perform effectively and reproducibly based on the approved process method and specifications.