Friday, October 31, 2008




1.1 It is established to access quantitatively microbiological status (microbial contamination levels) of the critical environments.


2.1 It is applicable in the pharmaceutical controlled/clean rooms.

3.1 Quality Control Manager
3.2 Microbiologist
3.3 Quality assurance officer
3.4 Micro-Lab.Assistant
4.1 Suitable Apparatus:
4.1.1 75-mm Diameter Petri Plates
4.1.2 Aluminium Foil
4.1.3 Conical Flask 250 ml
4.2 Suitable Equipments:
4.2.1 Air Sampler
4.2.2 Incubator @ 37°C
4.2.3 Hot Air Oven
4.2.4 Autoclave
4.2.5 Colony counter
4.3 Media Required:
4.3.1 Nutrient Agar
4.4 Autoclavation of Apparatus:
4.4.1 Wash the petri dishes with a suitable detergent.
4.4.2 Place & dry them in a suitable Hot Air Oven, Thermostatically controlled, capable of maintaining the temperature at 80•C.
4.4.3 Sterilize the apparatus at 121 °C for about 20 minutes

4.5 Preparation / Autoclavation of Media (Nutrient Agar):
4.5.1 Dissolve required quantity of Nutrient Agar Media as directed on its label in 100 ml of distilled water by boiling.
4.5.2 Autoclave in a steam sterilizer at 15 lb pressure (121 °C) for 18 to 20 minutes
4.5.3 Congeal a uniform (25ml) layer of the media in in Petri dishes under Laminar Air Flow Hood & let it to solidify, cover and invert the plates.
4.5.4 Incubate for at least 24 hours to check for any growth.

4.6 Methodology:
4.7.1 Define the Sampling sites in the critical area.
4.7.2 Charge the battery of the air sampler.
4.7.3 Adjust the sterilized Nutrient Agar Plate in the Sampling Equipment under LAF Hood and transfer the charged equipment in the sampling sterile area.( Keep one Petri plate unexposed as negative control.)
4.7.4 Switch on the Sampler to suck the air through perforated lid and to fall it on the Agar Plate in aregular pattern.
4.7.5 Transfer the Device to the Microbiology Laboratory aseptically.
4.7.6 Discharge the Plate & incubate @ 35°C for 48 hours.
4.7.7 After completion of incubation time calculate the colony forming units (CFUs) for their acceptance criteria.(The number of sampling Plates may Be increased according to the running situation)



1.1 This procedure is established to describe the system for satisfactory work of HEPA filter.

2.1 It is applicable in the sterile areas.
3.1 Quality Control manager
3.2 Microbiologist/Quality Control Officer
3.3 Micro-Lab attendant

4.1 Wipe clean the outside surface of the particle counter and other accessories required for monitoring and keep them in the UV pass box for 30 minutes for irradiation before taking them inside the sterile room for monitoring. While monitoring the HEPA filter in the component preparation area just wipe clean the particle counter and take it in room.
4.2 Keep All The Laminar Flows “On” in the room and using the MetOne particle counter at an air flow rate of 1 cubic ft. Per minute. Slowly scan each and every HEPA filter by passing the probe slowly across the filter surface at a distance of approximately six inches and working in a gird Pattern until the entire surface has been scanned with the instrument adjusted to detect particles of size 0.5 micron.
4.3 For each HEPA filter using the probe, scan the seal of each filter element to its frame and the seal between the filter frame and the filter housing to verify that particulates are not escaping around the filter.
4.4 Make a diagram of the filter surface and indicate the location of any point where there is a sudden increase in particle count.
4.5 Record all the particle count readings and compare them with the acceptance limits.

4.6 Also determine the particle count in clean room at different locations and compare it with Acceptance limits.

5. Interpretation of results

The displays shows the results of particles in Cubic Ft/ M which should be required to convert into Cubic meter, So
1 Cubic meter / M = Display in Cubic Ft/M x 35.31
= Particles in Cubic meter / M


The test is established to evaluate the microbiological status of the pharmaceutical clean rooms and the controlled environment.
2.1 It is applicable in the pharmaceutical aseptic zones.
3.1 Quality Control Manager
3.2 Microbiologist
3.3 Production Officer (concerned)
3.4 Lab. Attendant (Micro)
4. Suitable Apparatus/Equipment/solution/media:
4.1 Petri dishes (sterilized)
4.2 Nutrient agar medium (sterilized)
4.3 Saline solution (sterilized)
4.4 Cotton swabs
4.5 Dry heat oven
4.6 Autoclave
4.7 Incubator at 30-35ºC

4.2.1 Preparation of petri dishes: Wash petri dishes thoroughly with water, finally rinsed them with distilled water. Sterilized them by placing in dry heat oven for 2 hours at 210-220 ºC.

4.2.2 Preparation of media (nutrient agar):

Media should be prepared, autoclaved and dispensed as directed by the manufacturer. Nutrient agar medium:

Prepare as directed by manufacturer. Dispense the medium in Petri dishes cover with butter paper or aluminum foil and autoclave as described by manufacturer. After autoclave final Ph should be same as recommended by manufacturer.

4.2.3 Methodology for Irregular surfaces: Dip the cotton swabs in 2-4 ml of saline solution and autoclave at 121◦C. Define the sampling places/surfaces in the subjected area. Transfer the vessels containing swabs aseptically to the sampling site. Rub/Swab on the surface to be monitored by selecting an appropriate area. Put the subjected swab back in to the vessel and transfer to the Microbiology Lab. aseptically. Under L.A.F Hood uncover the petri plate and impregnate the swab on the surface of nutrient agar. Incubate at 30-35 ºC in incubator for 48 hours.
4.2.4 Methodology for Regular surfaces: Similar process as above Use S.S. template having an area of 25cm2 for regular surface monitoring.

The following Quality Records shall be generated and managed in accordance with the Procedure for Control of Company Quality Records (4.12).

Required Record
Quality Record No.
Swab Test Report

Traditional Medicine: Definitions

The following terms are extracted from the General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine.Click here to view entire document [PDF 216KB]
Traditional medicine
Traditional medicine is the sum total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.
Complementary/alternative medicine (CAM)
The terms "complementary medicine" or "alternative medicine" are used inter-changeably with traditional medicine in some countries. They refer to a broad set of health care practices that are not part of that country's own tradition and are not integrated into the dominant health care system.
Herbal medicines
Herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products, that contain as active ingredients parts of plants, or other plant materials, or combinations.
Herbs: crude plant material such as leaves, flowers, fruit, seed, stems, wood, bark, roots, rhizomes or other plant parts, which may be entire, fragmented or powdered.
Herbal materials: in addition to herbs, fresh juices, gums, fixed oils, essential oils, resins and dry powders of herbs. In some countries, these materials may be processed by various local procedures, such as steaming, roasting, or stir-baking with honey, alcoholic beverages or other materials.
Herbal preparations: the basis for finished herbal products and may include comminuted or powdered herbal materials, or extracts, tinctures and fatty oils of herbal materials. They are produced by extraction, fractionation, purification, concentration, or other physical or biological processes. They also include preparations made by steeping or heating herbal materials in alcoholic beverages and/or honey, or in other materials.
Finished herbal products: herbal preparations made from one or more herbs. If more than one herb is used, the term mixture herbal product can also be used. Finished herbal products and mixture herbal products may contain excipients in addition to the active ingredients. However, finished products or mixture products to which chemically defined active substances have been added, including synthetic compounds and/or isolated constituents from herbal materials, are not considered to be herbal.
Traditional use of herbal medicines
Traditional use of herbal medicines refers to the long historical use of these medicines. Their use is well established and widely acknowledged to be safe and effective, and may be accepted by national authorities.
Therapeutic activity
Therapeutic activity refers to the successful prevention, diagnosis and treatment of physical and mental illnesses; improvement of symptoms of illnesses; as well as beneficial alteration or regulation of the physical and mental status of the body.
Active ingredient
Active ingredients refer to ingredients of herbal medicines with therapeutic activity. In herbal medicines where the active ingredients have been identified, the preparation of these medicines should be standardized to contain a defined amount of the active ingredients, if adequate analytical methods are available. In cases where it is not possible to identify the active ingredients, the whole herbal medicine may be considered as one active ingredient.

Saturday, October 25, 2008


Pharmacy (from the Greek φάρμακον 'farmakon' = drug) is the health profession that links the health sciences with the chemical sciences, and it is charged with ensuring the safe and effective use of medication. The scope of pharmacy practice includes more traditional roles such as compounding and dispensing medications, and it also includes more modern services related to patient care, including clinical services, reviewing medications for safety and efficacy, and providing drug information. Pharmacists, therefore, are the experts on drug therapy and are the primary health professionals who optimize medication use to provide patients with positive health outcomes. The term is also applied to an establishment used for such purposes. The first pharmacy in Europe (still working) was opened in 1241 in Trier, Germany.