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Julphar Training

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asaad mohamed

on 13 September 2015

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Transcript of Julphar Training

Julphar is one of the largest pharmaceutical manufacturers in the Middle East and North Africa (MENA) producing and distributing generic medicines to over 40 Countries. 
Established in 1980 in UAE and the first stand-alone facility produced only five products

Julphar currently operate twelve internationally certified manufacturing facilities globally, producing over a million boxes of medicines daily and hold 3,646 product certificates.
Eleven of its Facilities are based in UAE and cover production areas including Tablets, Syrups and Suspensions.
In 2013, Julphar launched a twelfth manufacturing facility in Ethiopia, as part of the ongoing international expansion strategy.

Julphar manufacturing facilities
Julphar currently operate twelve internationally certified manufacturing facilities globally

• Julphar I (Pharmaceutical Solid Dosage Forms)
• Julphar II (β-Lactam Antibiotics and Sterile Dosage Forms)
• Julphar III (Oral Penicillin Plant)
• Julphar IV (Oral Cephalosporin Plant)
• Julphar V (Off-line Packaging Plant)
• Julphar VI (Liquid and Semi Solid Pharmaceutical Dosage Form)
• Julphar VII (Biotech Lab and Production Facility)
• Julphar VIII (Sterile Powder Filling Plant)
• Julphar IX (Sterile Cephalosporin Powder Filling Plant)
• Julphar X (Semi-solid plant)
• Julphar XI (Julphar Diabetes – Insulin Plant) 
• Julphar Ethiopia Facility (Ethiopia Plant)

Julphar decided to focus on innovation in Biotechnology with the launch of a $150m Manufacturing Facility entirely dedicated to producing Raw Material needed for Biosimilar products.
Today, this facility is the only plant in the MENA region that produces insulin using insulin crystals derived from r-DNA technology.

Julphar produces therapeutic products which target a large range of pharmaceutical segments including  consumer, endocrinology , antibiotics, cardiovascular, women‘s health, dermatology and gastroenterology.

Julphar I
Pharmaceutical Solid
Dosage Forms
Weighing area
Procedure followed in the dispensing area to receive raw materials :-

• Julphar IX
Thank You
Julphar Training
Ahmad monther Anam Tufail
Dina Abdal Rahman Fatemeh Iravani
Hanan Salam Joelle Hako
Manal Abbas Ola Asaad
Ward Saidawi Zainab Namvar



Equipments used for solid dosage forms
Rotta F and Rotta P used for wet granulation
Aromatic dryer for drying
Bowel lifting device for lifting the bin and loading the granules
Frewitt used for grinding and milling
Russel used as sifter
Dumbler mixer to mix the powder
Silversan used for coating
Kilian and Fette used for compression
Roller compactor to increase the tablet hardness

Solid dosage forms production process
Production send email to the storage and weighing area

Receive materials from stores

Receive MIV (material issue voucher) and match it with MFM (manufacturing formula )

Put the material in stainless steel instead of plastic containers

Weighing procedure
Making a check list

Calibration of the balance

Record everything in the log book

Rechecking the total and the tare weight in dispensing area

Put all the MIV material in one cage

Good practices during weighing
Door is clean.
Scale cables are clean.
Scale is clean.
Tables are clean top, bottom and inside.
Floor is clean including the corners.
Check the side walls, exhausts compressed air and nitrogen pipe.
There is no traces of previous products.

(Sterile Cephalosporin Powder Filling Plant)
Julphar IX is a facility dedicated to the filling of dry powder injection vials.
Powder filling occur under luminal floor with 122 vacuum.
washing, receiving and labeling area is class 100000.
Also using isoprpanol for regular cleaning.
Julphar is following standards for cleaning and monitoring. All workers should wear gowns, masks and gloves.

Julphacef (Cephradine 250mg or 500mg)

Cefuzime (cefuroxime sodium )

Primocef (Cefotaxime)

Production procedure
Preheating zone ( receiving zone )

(Vial washing machine (showering

Pumping hot water for injection to the vials then pumping compressed air

vials in dry hot tunnel in 310C for 10 – 15 mins

Cooling zone to reduce vials temperature to 20 C

Pre-filling weighing

Vial filling machine using BAUSCH and STROBEL machines

Post filing weighing

Quality Control ( chemical, physical and microbiological sections )
Example of quality control chemical check on raw materials
Physical analysis
Dissolution test

Friability test

Hardness test

stability studies
Microbiological testing
There are 3 types of liquids
:

1- drops
2- suspension
3- syrup

Process of profinal 110ml…
The same process except that no measurement cap added and the cap has a dropper instead. A dropper is added because dose has to be extremely accurate especially when given to kids.

Warehouse
Consist of :

1.Receiving area
2.Quarantine Area
3.Transit Area
4.Main store
5.Out stores

Document are given by supplier , julphar check if they are correct and then place them in the secondary area and put yellow label called quarantine label.
If product get accepted it become green label, if rejected >> RED label.
Later, samples are taken for quality control. For API all tanks must be opened.

Finally in the RELEASE area, yellow and green label gets approved.
ORANGE label means samples has been taken from it.


Lab coat
Head and shoe cover
15-25 degree C
RH 65-70%
Silica gel for rats
If needed, product gets stored in fridge.

GMP
Products sent to outside the country must have all the safety measures required for transportations and the truck must match the storage conditions of the product.

Regulatory affairs
Main documents required for registration
Formula
Raw Material specification
In process control
Finished Product specification
Manufacturing Method
Method of analysis
Certificate of analysis
Stability report
Pharmacological & Toxicological report

Other documents that may be required according to the Authorities requirements
Registration certificate in the country of origin
GMP Certificate of company
License of Certificate
ISO Certificate
Prices in origin
Bioequivalence study
Source of the raw material

Material planning
This department located in Julphar 6
This department is responsible of planning and coordination between the different departments of the company For example: they send purchase orders of shortcomings in the factory or company, whether raw materials or packaging materials through documents known as RMPS ( Raw Material Purchase specification ) and PMPS (Packaging Material Purchase specification ) .
also, they sends the documents to the store known as (MFM - Manufacturing Formula & Method ) in order to ensure availability of raw materials and quantities necessary for the manufacture of a specific product. MPI or Master Packaging Instruction also sent to the store to insure the availability of packaging material for a product
1- Receiving area
This is where they receive Raw Material and Packaging Material and first checked from the outside without opening the containers by comparing it with what is in the purchase order and then they put the yellow color sticker which contains the basic data as the name of the material and supplier, quantity and code number.
Then selected samples from the containers sent to the Quality Assurance which in turn send samples to the Quality Control which check raw material, for example, ensure the presence of the active ingredient with ordered concentration and several other tests . The Raw Material samples are taken of them in private areas sterile and hygienically safe. Entry to these areas are authorized is limited
After taking the sample containers labeled with orange color until QC determine whether the sample is accepted or rejected. Containers labeled with green sticker if sample accepted while Red label shall be placed on the rejected material then This shipment is transferred to the out stores to determine its fate, to be destroyed or returned to the supplier.


2- Quarantine Area
Quarantine Area: or what is known as the quarantine zone where shipments under test by the QA is stored to determine its fate of acceptance or rejection.

3 -Transit Area
This area consists of two parts, one for the transfer of materials to the manufacturing area and to transfer materials to different filling and packaging areas.

4 - Main Store
Main store of Raw Materials and Packaging Material sin addition to the Finished. These materials organized in A-Z alphabetical order:

A - J: Finished Products
K - P: Raw Material
Q - Z: Packaging Material

5 - Out stores
storage of materials that have been rejected after screening in addition to chemicals, gases and flammable materials which are used in laboratories.

Coating process
There are 2 types of coating sugar and film coating
A) Sugar Coating :
It is applied to mask unpleasant taste and odor of the ingredients, to protect ingredients from degranulation and to improve tablet appearance. It involves the building up of layers of coating materials on the original tablet core, as the tablet are rotated in a revolving coating pan.
The process of Sugar Coating occur as follows :
1- Sealing
2- Coating by : suspension coater (Spray , Distillation)
3- Drying
4- Polishing by wax

Film coating
Film Coating :
It is used to control the site of release of the drug, as it dissolves in the small intestine it can release the drug in the small intestine not in the stomach and at the same time protect the stomach from irritant drugs.

The process of Film Coating occur as follows :
1- Coating will be dissolved in volatile substance (such as water or Ethanol )
2- Plasticizer are added to prevent cracking of the coat
3- The coating material sprayed by Nozels
4- Automatic rotating and mixing

The machine also consists of air inlets and outlets. The machine of film coating is called JULPHA-COTA

Capsule filling process
Capsules Filling process :
1- Empty closed capsules are taken From the Hooper
2- The upper parts of capsules [capsules caps] are then separated from their bodies [lower part] by drawing them by application of vacuum
3- The Lower Part is then automatically placed adjacent to the Hooper containing the powder ingredients to be filled
4- The Filled capsules bodies are then automatically fitted with their corresponding capsules caps , by applying pressure
5- The filled closed capsules are finally ejected, then inspected for any defect and their weight are checked [if there any defect in weight of any capsule it will be rejected] and then finally packaged into containers.

Duradox -- Doxycycline Hyclate

Ginsavit – Ginseng ( soft gelatin capsules)

MEDICAL AFFAIRS DEPARTMENT

Pharmacovigilance
Pharma: Drug
Vigilance: Awareness or to keep an eye on.

Pharmacovigilance (PV) :
Science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug related problems.
(WHO,2002)

WHY PV IS NEEDED ?
Limitations of clinical trial safety data .

Aims of PV
Improve patient care and safety.
Improve public health and safety in relation to the use of medicines.
Detect problems related to the use of medicines and communicate the findings in time effective manner.
Contribute to the assessment of benefit, harm, effectiveness and risk of medicines .

Partners in PV
Government
Industry
Hospitals and academia
Medical and pharmaceutical associations
Poisons and medicines information centers
Health professionals
Patients
Consumers
The media
World Health Organization (WHO)

Definitions

Any un toward medical occurrence in a patient administered a medicinal product and which doesn’t necessarily have to have a causal relationship with this treatment.

Adverse Events :

All noxious responses to a medicinal product , its directly caused by the drug at normal dose during normal use
Adverse Drugs Reactions:
Periodic Safety update report writing
The PSUR can be an important source for the identification of new safety signals, a means of determining changes in the benefit-risk profile, an effective means of risk communication to regulatory authorities and an indicator for the need for risk management initiatives, as well as a tracking mechanism monitoring the effectiveness of such initiatives. For these reasons, the PSUR can be an important pharmacovigilance tool.
Numerous steps are involved in the PSUR process including: intake of adverse drug reaction information, case processing, data retrieval, data analysis, and medical review and risk assessment. These processes are heavily reliant on the availability of adequate resources.


Once marketed 6 monthly for 2 years , yearly for another 2 years , and 5 yearly at renewal.




1.Brief product information
2.All non serious, serious listed case reports
3.Marketing Authorization status
4.All new information with the product in US FDA
5.Overall safety evaluation

PSUR Timeline:
PSUR inclusion:
Quality Assurance
Proving evidence needed to establish quality in work.
Introduces the rules ‘fit for purpose’ and ‘do it right the first time’
QA is the planned and systemic activities implemented in quality system but QC is the observation techniques and activities to fulfill requirements for quality.

QA Functions
SOP writing, reviewing, distributing and control of Standard Operating Procedures.
1. Purpose
2. Scope
3. Definition and abbreviation
4. Responsibility
5. Procedure – all SOPs must be in brief, simple language that is easy to understand.
6. Attachments
7. SOP distribution
8. Reason for revision

QA Functions
Validation and Qualification
Equipment validation
Facilities validation
Cleaning validation
Process validation
Analytical method validation
Computer system validation

Design Qualification (DQ)
Installation Qualification (IQ)
Operation Qualification (OQ)
Performance Qualification (PQ)

Internal Auditing
Market Complaint
Deviation and CAPA
- any non-compliance of an established GMP standard or of approved requirements, specifications and SOP.
CAPA- Corrective and preventive action

QA Functions
Deviation and CAPA example:
Deviation: Sticking on tablet
Root cause: Damaged punch
Correction: Quarantine the compressed tabket and sort
Corrective action: Remove punches and use new one after verification
Preventive action: Implement procedures to verify the punch condition before compression initiation
Implement procedures to replace the punches after certain usage period.
Change control
- to ensure that the system is maintained in validated state.
Batch document review-
the complete batch document must be reviewed and assured the quality of entire process

JULPHAR IV:
The Cephalosporins Plant
Overview:
Cephalosporins, like penicillins are allergenic to many people. To avoid cross-contaminating other products, they require a separate plant for the manufacturing of their dosage forms.
Julphar IV produces different cephalosporin solid dosage forms; such as tablets, capsules, and powders for reconstitution.
There are 8 sections in this plant, each dedicated for a step in the manufacture of the solid dosage forms: dispensing, blending, capsule, filling, tablet compression, coating, granulation, blistering, and quality assurance.

Plant Sections
1.

Dispensing (Weighing) Area:
Raw materials are weighed and filled here. The balance is calibrated first, and all weighing is done in a laminar flow cabinet utilising HEPA filters. When light-sensitive materials are involved, they are packed in black bags and sodium lamps are used for lighting.

2. Blending Area:
Raw materials are mixed then blended here. The Canguro Tumbler is used. The process is controlled using a programmable logic controller (PLC).

Dispensing Booth

Canguro bin tumbler

Plant Sections
3. Capsule Filling Area:
The capsule filling machine GKF 800 is used, which can fill 30 capsules at a time and also de-dust and polish the capsules made. Only hard gelatin capsules are produced.

4. Tablet Compression Area:
Granules are filled into the machines from rooms above: they are loaded into bins using a bin-loading machine, and lifted using a column to the top floor, which has a bin-washing station too. The tablet compression machine makes 36 tablets at a time.

GKF 800 encapsulator

Tablet compression machine

Plant Sections
5. In-process Quality Assurance:
quality control tests are done here, such as hardness, friability, weight variation, disintegration, and blistering leakage using methylene blue dye.

6. Coating Area:
The coating solution is mixed using the Silverson mixer, a pump delivers it to the coating machine which sprays it onto the tablets. Cephuzime tablets for example, are enterically-coated here.

Plant Sections
7. Granulation Area:
Granulation is sometimes needed but tablets are usually made by direct compression here. The Finex separator separates particles by size using sieves.

8. Blistering Area:
There are separate areas for blistering tablets and capsules using different machines. The tablets or capsules are poured into the hopper of the machine which then packages them automatically.

Blistering machine
let's START ....
Product Development Laboratory
Product development Laboratory (PDL) also known as Research and development is responsible for the formulation and synthesis of new generic products.
As defined by FDA, a generic drug must be identical, or bioequivalent to an innovator drug in dosage form , safety, strength, route of administration, quality, performance characteristics, and intended use. It may differ in the use of excipients.
Julphar is the only pharmaceutical industry in UAE to have this department.
It takes two years to launch a new product in the market.
Development of a new product is a complex process involving series of steps which is accomplished in collaboration with other departments.

Steps in Product Development
1. Initiation
New Products Committee (NPC) , a part of the marketing team post the market analysis sends “Product approval” for development to PDL.
2. Design
Procures the bench mark product for study and set specifications.
Requests for the marketing requirements , brand name , art work design etc.
Searches literature about the product , API and excipients.
Designs the formulation for experiments.
Orders the raw materials required.
On receipt sends for analysis and certificate of analysis.

3. Experiments
Conducts PDL experiments
Finalizes the trial formulation (small samples)
Sends samples to analytical lab. If the samples passes the analytical test they proceed to the next step.
4. Stability tests
Prepares PDL or laboratory scale batches : three stability batches for accelerated and long term stability study.
5. Organize resources
Requests for leaflets , Pharmacology from medical writing department.
Requests for packaging materials for secondary packaging.
Prepares purchase specifications of materials (API & excipients).
Prepares draft MFM for pilot batch (10% of commercial batch).
Orders materials for bioequivalence (BE) study and pilot batch in production facilities.


6. Scale up batch
A pilot batch is manufactured in plant for BE/stability study. The role of the pilot scale batch is to provide data predictive of the production scale product. It may be necessary to further develop and optimize the manufacturing process using pilot scale batches. The pilot batch therefore provides the link between process development and industrial production of the product.1
Prepares registration and BE samples.

7. Dossiers
Regulatory affairs prepares registration dossier as per MOH.
Reviews documents.
Submits to RA with samples.
1-http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002913.pdf

8. Validation
Prepares final MFM , Purchase specifications.
Requests to order material to planning.
Requests for validation protocol for full scale batches documents.
3 validation batches are manufactured.
Post approval stability study.

9. Technology Transfer*
Prepares tech transfer protocol and report.
Reviews documents.
Closes out the project.
Ongoing stability study is performed for confirmation of shelf-life and storage conditions (quality) for marketed products.

10. Launching the product
* Technology transfer refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full-scale commercialization or it is the process by which a developer of technology makes its technology available to commercial partner that will exploit the technology.2
2-http://www.pharmatutor.org/articles/overview-of-technology-transfer-in-pharmaceutical-industry

It is a mix of science and management to achieve a commercially important goal within a drug-development organization.
It includes everything related to drugs from the earliest non-clinical studies, development, drug registration in the ministry of health in UAE and other countries, and marketing.
Company registration must be done prior to product registration
Companies for conventional, general sale, medical devices and herbal should be registered by health authorities
The approval time is 3-6 months

EXAMPLE OF REQUESTED INFORMATION
Application form of UAE
Letter of agency authorization
Legalized company License
List of subsidiaries
List of products produced by company
List of countries where company is registered
Research information
Receipt of fees information
Company profile
List of associated manufacturing faculties

Registration Requirements of a Company
Registration of Products
The department prepares a file for each product in the company which contains all the data related to the medication which is required in order to register the product then they send this file with a random sample of the product to the ministry of health. MOH examine the product and make sure it matches the data and specifications mentioned in the file with the sample .

Registration of New Product in U.A.E
Typical Procedure
Duration: 12-24 months
May be subject to stops or a continuous process
Speed to market - Early approval to market is more important than early submission of a dossier


Renewal of the Product Registration
Total Number of Products Registered in UAE till 2014
Total Number of Products Registered in Different Countries

Julphar VI
( Production and packaging) liquid plant
Example of quality control chemical check on raw materials
Nasal and mouth drops
1- Primary material ( bottles ) gets incoated with liquid.
2- De-palletizer will carry the bottles.
3- De-packer will open the bunddle going to the round table.
4- Blower will clean bottles using vaccuum.
5- Filling with syrup in separate area upon certain measurement.
6- capping machine
7- inspection area to check volume and any default, plus checking any cap damage.
8- labeling machine. Adding expiry date and batch number.
9- cartoner will add the label automatically.
10- automatic closure of the box.
11- checkweigher measures the weight and by air it push default bottles into weight rejected box..
12- casepacker add tube up and down and is responsible for packaging. Machine stops automatically if anything is missing.

Marketing
is a business of advertising and communicating by which individuals obtain what they need through creating and exchanging products and their value with others


Aim
The main mission involves activities concerned with finding out what consumers want, and producing the highest possible quality, and then providing it for them.
To build a trust with the consumers and the medical community by assuring the quality and the availability of julphar products.

Marketing Mix

A useful starting point used to carry out market research to find out about customer requirements. This involves the four key elements , which are referred to as the 4P’s(the marketing mix).

Marketing Plans
Marketing plans are vital to marketing success. They help to focus the mind of companies and marketing teams on the process of marketing i.e. what is going to be achieved and how we intend to do it. There are many approaches to marketing plans.
The key stages of marketing plans are contained under the popular acronym AOSTC.

Stage one
:

Analysis
Marketing Environments
Laws and regulations
Politics
The current state of technology
Economic conditions



Sociocultural aspects
Media availability
Marketing plans and campaigns of competitors
Internal factors such as your own experience and resource availability






Stage Two:

Objective (SMART Objectives)
Specific - Be precise about what you are going to achieve.
Measurable - Quantify you objectives.
Achievable - Are you attempting too much?
Realistic - Do you have the resource to make the objective happen (men, money, machines, materials, minutes)?
Timed - State when you will achieve the objective (within a month? By February 2010?).

Stage Three:

Strategies (Describe your target market)
Which segment? How will we target the segment?
Why this segment and not a different one?
Why this segment and not a different one?

Stage Four:

Marketing Tactics
Convert
the strategy into the marketing Mix.
PRICE
Will you cost plus, skim, match the competition or penetrate the market?
PLACE
Will you market direct, use agents or distributors, etc?
PRODUCT
Sold individually, as part of a bundle, in bulk, etc?
PROMOTION
Which media will you use?

Stage Five:

Marketing Control
Start-up costs.
Monthly budgets.
Sales figure.

Market share data.
Consider the cycle of control.
Role of Medical Information & Education Unit:
Integrate Clinical and Scientific Knowledge with the Commercial Dynamics of the Pharmaceutical Industry.
provide Medical and Scientific support
1. Creat updated and balanced scientific response according to the medical inquiries.

2. Reviews the medical literature to identify data that support the company product lines.

3. Serves as a medical resource in preparing & writing the promotional tools.

4. Interact with JTC to assist in improving education & product knowledge training sessions necessary for the sales force.

5. Participate in publication and training materials reviews to ensure manuscripts are scientifically balanced.

6. Provides support on National Conferences and Medical Meetings.
7/6/2015 to 11/6/2015
Semisolid dosage form


Julphar X
Annual Capacity - 60 million Tubes of Creams and Ointments, 200 million Suppositories

WHAT IS SEMISOLID DOSAGEFORM?

Semisolid dosage from is something that is not really a solid or a liquid, it’s something between them.

Semisolid dosage form produced in julphar includes :

Manufacturing process:

All the process is automated. Staff is only controlling it through computers

Step1:
Water Phase & Wax Phase & Manufacturing Phase: Add water soluble ingredients into the container than heat with stirring . Water phase will be transferred to the main containers by pumps through pipes .
Step2:
add wax in the into main container than again heat with stirring . After complete melting and mixing of wax than to be added drugs and ingredient in same container and mixed by stirrer.
(Machine is jacketed vessels)

Step3:
The Mixed material will be passed through colloid mill for particles size reduction and homogenize mixing before cooling the mixture.
(Machine: Colloid Mill) 

jacketed vessels
Colloid Mill
Step4:
After the mixture is homogenized it will transferred through pipes into sweep agitator for cooling slowly to be moved after that into storage tank or drum
(Machine : Sweep agitator)

Sweep agitator
Step 5:
The material will be store in the storage tank and this tank having facility for heating and trolley wheel for move to filling area. 
(Machine –Storage Tank)

Step 6:  
The storage tank carry to filling machine then the material will be heated by hot water circulation for easy transferring high viscous material by metering pump to the hopper of filling machine . 
( Machine :Metering Pump)

Step7:
The Ointment/ Cream will be fill and seal by filling machine and packed by packing line machinery. 
(Machine –Filling & Sealing and Packing Line Machinery)

Filling & Sealing and Packing Line Machinery
Flowchart process

Documents required for drug registration
These data related to raw materials, composition, method of manufacturing in details, processing conditions, tools and equipment used in manufacturing also the method of analysis used, the devices used in analysis and all the tests done during and after Manufacturing. There is also a report of the Stability tests done. Finally, there is the report of the effects of the medicine in general, and toxicity.
Any change in the product should be included in the file.

Requirements for a Generic Drug
Same active ingredient
Same route of administration
Same dosage form
Same strength
Same conditions of use

Quality control department checks the chemical, physical and microbiological integrity of the raw materials and in process samples.
Chemical analysis checks purity, particle size, polymorphism, water content, weight and PH according to USP criteria.
Physical analysis checks the content uniformity thickness, hardness, disintegration and dissolution.
Microbiological analysis: Sterility or resistance to microbial growth is retained according to the specified requirements. Antimicrobial agents that are present retain effectiveness within specified limits

Stability studies is done on formulations from the product development laboratory (PDL) to check the stability of the products, the rate of degradation and degradation products.
Also after marketing products are tested under indicated storage conditions to stimulate what happen in the market.
In julphar they have two types of chambers walk in chambers and reach in chambers.
Long term stability studies occur at 25 C and 60% RH
Accelerated stability studies occur at 40C and 75% RH

In Julphar microbiological testing is done on the final products ( samples from the batch ). Also checking in process samples.
There are many types of agars depending on the type of organism we test for and the culture media .
In the lab agars prepared under luminal floor by pouring the culture media and left to solidify.
There are different types of growth medium we saw like blood and liquid growth medium.
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