CLINICAL TRIAL FACILITIES

Don Valley Pharmaceuticals (Pvt) Ltd is affiliated with Akram Medical Complex Lahore, a leading name in the Healthcare sector.

Akram Medical Complex is well equipped to carry out clinical trials of new medicines and also has well equipped pathological and microbiological laboratories, run by well trained doctors and pathologists. All our new drugs are approved after successful clinical trials, which are carried out at Akram Medical Complex.

DEPARTMENTS

Team Coordination

1- Chief Executive Secretariat
2- Marketing Department
3- Finance Department
4- Human Resource Department

The presence of all the departments under one roof helps us in better coordination and improvement in the efficiency of the company. In addition, well-equipped small and big conference rooms have also been designed for meetings and training.

Changing Rooms:

This area has great significance for the working of the factory and the hygienic conditions, which provide a clean atmosphere for operations whilst taking care of the staff comforts thereby providing an efficient working environment.

Canteen:

The canteen area has been constructed in a separate block and has a self-service system to serve food and drinks. This block contains well-furnished dinning halls with all amenities of drinking water and air conditioning facilities.

UTILITIES

The following utilities are available for the operations of our manufacturing plant:

  1. Electricity
    500 Kv transformers, 350 Kv Generator (As a Stand by), LT Panel
  2. Water system
    Turbine / over head Tank, RO Water apparatus, Deionizer, Distillator
  3. Steam
    Boiler (2 tons), Storage Tank
  4. Compressed air
    Compressor capacity
  5. HVAC System
    Chillers 2 X 150 TR, AH Units (18)
  6. Other Requirements
    Smoke Detector, Fire alarm, Security alarm, Fire fighting system

HVAC System

It is essential to create a suitable environment in the manufacturing area to produce good quality products. Our HVAC System consists of the following factors, which we have implemented at our manufacturing plant:

1- Air Conditioning 
2- Dust Collecting 
3- Humidity Control
4- Bio-Burden (Minimum Rate)
5- Air Changes/hr.
6- Differential Pressure

BACK UP Services

We employ well-equipped and trained technical staff for the maintenance of our manufacturing plant and back-up services. Our workshop provides large areas to carry out maintenance. Following is the detail of our technical staff:

1- Maintenance Engineer 
2- Mechanical Supervisor
3- Electrical Supervisor
4- HVAC Supervisor
5- Boiler Engineer

GMP: DONVALLEY HAS TOTAL COMMITMENT TO QUALITY

GMP is a set of regulations, codes and guidelines for the manufacture of drugs. 

Other “Good Practice” system, along the lines of GMP exist; Good Laboratory Practices for laboratories conducting non-clinical studies (Toxicology and Pharmacology studies in animals), “Good Clinical Practices” for hospitals and clinicians conducting clinical studies on new drugs in humans, and Good Distribution Practices (GDP) for wholesalers and distributors. Collectively these good practice requirements are referred to as G x P requirements and all follow the highest level of commitment to quality. GMP is a concept that goes beyond manufacturing; it involves a commitment to total quality across our organization.

QUALITY CONTROL SECTION

It consists of four major sections:

1- Chemical Section
2- Components Section
3- R & D Section
4- Microbiological Section

Important Quality Instruments and view of the laboratory:

1- HPLC
2- Spectrophotometer
3- Karl Fischer Titrater 
4- Brook Field Viscometer 
5- pH Meter
6- Disintegrator
7- Dissolution Test Apparatus
8- Water Distillatory

Quality Techniques for Pharmaceutical Manufacturing

In the modern world these techniques play an important role to streamline the manufacturing processes and create a higher level of confidence in our products. At Don Valley, we give the highest emphasis to these concepts.  

1. In Vitro Drug Dissolution Testing

Dissolution may be defined as the amount of substance (Drug) that goes into a solution per unit time under standardized condition of solvent composition and agitation (Stirring).

2. Shelf Life and Stability Testing of Pharmaceuticals

There is high variation of climatic conditions in our country and awareness about the medicines storage is limited. Therefore it is essential that the products must be tested for stability in variable conditions of temperature and humidity. The scientific content includes aspects of setting a stability program, storage conditions and examination intervals, as well as analytical procedures to determine purity and to detect impurities, material specifications and packaging considerations. We are well equipped to carry out the stability processes and the effective use of resources is covered through the planning of the stability program.

Innovation in packaging

Hologram does not only provide us brand security but also contributes towards Packaging Aesthetics, hence providing us better brand value. Packing designing is an art that requires a lot of knowledge about the latest market trends and acceptability. Our Quality Assurance Laboratory has a separate packing components section, which is responsible for components selection and testing its suitability according to the formulation of the drug.

JOURNEY TO OUR FACTORY

31Km Ferozepur Road, Lahore 

Factory Site: 

An all green beautifully landscaped area has been chosen for the factory site, a unique architecture design of the red bricks building, which gives an elegant look to the entire factory.

Head Office:

The first floor of the factory has been allocated for the head office, which is nicely furnished, producing an excellent working environment. All communication systems have been mechanized to create a quick flow of information.

MANUFACTURING ACTIVITIES

Our manufacturing plant has been designed according to the Drugs Act of Pakistan and GMP requirements. The new project consists of the following sections:

1- Ampoules / Vials Section
2- Liquid Section
3- Tablet Section
4- Cream / Ointment Section
5- Ophthalmic Drops Section
6- Anti-Biotic Oral Section
7- Anti-Biotic Sterile Section
8- Sterile Ampoules Section
9- Sterile Dry Vial Section
10- Cephalosporin Oral Section
11- Cephalosporin Sterile Section
And, Anti-Cancer Drugs

All these sections have been equipped with GMP certified machines, which produce high quality products. We have deputed well-trained staff to operate these sophisticated machines.

Solid Dosage Form:

A solid oral dosage form is easy to ingest and relatively more stable than the others. Almost two-third of our production falls in this presentation. The formulation of compressed solids involves highly intricate series of events, from the characterization of the active pharmaceutical ingredients, to the choice of recipients, to the selection of processing, compression, and coating equipment and packaging systems appropriate for the specific drug and the dosage form.

Our manufacturing facility meets all the GMP and regulatory requirements of manufacturing solid dosage whilst making sure of contents uniformity and avoiding any and all types of cross contamination. We meet all the pharmaceutical standards of disintegration and dissolution and our compressed solids are applied aqueous film coating. Accuracy of equipment is maintained to produce quality products. We have modernized our operations and have acquired the latest following equipment to produce solid dosage form:

1- Blenders
2- Ribbon Mixers
3- Tumbler 
4- High Shearing Mixer (at New Factory) 
5- Fluidized Bed Dryer Glatt Type (at New Factory) 
6- High Speed Rotary Compression Machine (at New Factory) 
7- Coating Pan 
8- Fully Automatic Coating System (at New Factory) 
9- Automatic Blister Packing Machine

In new products and in the case of change of source of active raw material, a stability test is carried out. We have all the facilities to carry out the stability of the products at different temperature. 

The tablets area is divided into four different sections, which are completely segregated to avoid cross contamination and to create the required environmental conditions of each section.

Dosage Liquid Products:

Liquid Products consist of Syrup, Suspension and Drops all of which are non-sterile. The consideration of prime importance for liquid drugs includes solubility of active drugs, preservation, taste masking, viscosity, flavoring, appearance and stability (Chemical, Physical and Microbiological), raw materials, equipment, the compounding procedures (often the order of mixing) and finally the packaging (to allow a stable product to reach patients).

Our main emphasis is on the stability of the drug in the liquid form (flavors and taste are also important). The provision of pure water is also a very important factor in our manufacturing process, which must be free from all contamination. Our manufacturing facilities use R/O Water and De-ionized Water for manufacturing.

Basic equipment is used for liquid preparations but they occupy large spaces such as Glucose Storage, Liquid Mixing and Liquid Storage Tanks, as well as Silverson, Syrup Filtration System, Liquid Transfer Pumps, Automatic Liquid Filling / Capping Machines, Bottle Blowing System, Filled Bottle Inspection System and Automatic Labeling Machines.

As per SOP's complete validation is carried out maintaining the following validation records:

1- Process Validation 
2- Cleaning Validation
3- Packaging Validation
4- Computer System Validation

DRY SUSPENSION / SYRUP / CAPSULES AND SACHETS:

These products have been classified in three categories:

1- Non-Antibiotic
2- Antibiotic (Penicillin Based)
3- Antibiotic (Non-Penicillin)

Each section has been completely segregated to avoid any cross contamination. Efficient Dust Extraction System has been installed in the sections where powder products are produced. Although all our formulations have simple processes and are easy to manufacture but the filling stage needs a lot of precaution and accuracy.

The following Hi-Tech machines are involved:

1- Semi-Automatic Powder Filler
2- Automatic Encapsulation Machine
3- Automatic Blister Packing Machine
4- Auto Labeler
5- Automatic Strip Packing Machine
6- Automatic Sachets Filler

CLINICAL TRIAL FACILITIES

Don Valley Pharmaceuticals (Pvt) Ltd is affiliated with Akram Medical Complex Lahore, a leading name in the Healthcare sector.

Akram Medical Complex is well equipped to carry out clinical trials of new medicines and also has well equipped pathological and microbiological laboratories, run by well trained doctors and pathologists. All our new drugs are approved after successful clinical trials, which are carried out at Akram Medical Complex.

DEPARTMENTS

Team Coordination

1- Chief Executive Secretariat
2- Marketing Department
3- Finance Department
4- Human Resource Department

The presence of all the departments under one roof helps us in better coordination and improvement in the efficiency of the company. In addition, well-equipped small and big conference rooms have also been designed for meetings and training.

Changing Rooms:

This area has great significance for the working of the factory and the hygienic conditions, which provide a clean atmosphere for operations whilst taking care of the staff comforts thereby providing an efficient working environment.

Canteen:

The canteen area has been constructed in a separate block and has a self-service system to serve food and drinks. This block contains well-furnished dinning halls with all amenities of drinking water and air conditioning facilities.

UTILITIES

The following utilities are available for the operations of our manufacturing plant:

  1. Electricity
    500 Kv transformers, 350 Kv Generator (As a Stand by), LT Panel
  2. Water system
    Turbine / over head Tank, RO Water apparatus, Deionizer, Distillator
  3. Steam
    Boiler (2 tons), Storage Tank
  4. Compressed air
    Compressor capacity
  5. HVAC System
    Chillers 2 X 150 TR, AH Units (18)
  6. Other Requirements
    Smoke Detector, Fire alarm, Security alarm, Fire fighting system

HVAC System

It is essential to create a suitable environment in the manufacturing area to produce good quality products. Our HVAC System consists of the following factors, which we have implemented at our manufacturing plant:

1- Air Conditioning 
2- Dust Collecting 
3- Humidity Control
4- Bio-Burden (Minimum Rate)
5- Air Changes/hr.
6- Differential Pressure

BACK UP Services

We employ well-equipped and trained technical staff for the maintenance of our manufacturing plant and back-up services. Our workshop provides large areas to carry out maintenance. Following is the detail of our technical staff:

1- Maintenance Engineer 
2- Mechanical Supervisor
3- Electrical Supervisor
4- HVAC Supervisor
5- Boiler Engineer

GMP: DONVALLEY HAS TOTAL COMMITMENT TO QUALITY

GMP is a set of regulations, codes and guidelines for the manufacture of drugs. 

QUALITY CONTROL SECTION

It consists of four major sections:

1- Chemical Section
2- Components Section
3- R & D Section
4- Microbiological Section

Important Quality Instruments and view of the laboratory:

1- HPLC
2- Spectrophotometer
3- Karl Fischer Titrater 
4- Brook Field Viscometer 
5- pH Meter
6- Disintegrator
7- Dissolution Test Apparatus
8- Water Distillatory

Quality Techniques for Pharmaceutical Manufacturing

In the modern world these techniques play an important role to streamline the manufacturing processes and create a higher level of confidence in our products. At Don Valley, we give the highest emphasis to these concepts.  

1. In Vitro Drug Dissolution Testing

Dissolution may be defined as the amount of substance (Drug) that goes into a solution per unit time under standardized condition of solvent composition and agitation (Stirring).

2. Shelf Life and Stability Testing of Pharmaceuticals

There is high variation of climatic conditions in our country and awareness about the medicines storage is limited. Therefore it is essential that the products must be tested for stability in variable conditions of temperature and humidity. The scientific content includes aspects of setting a stability program, storage conditions and examination intervals, as well as analytical procedures to determine purity and to detect impurities, material specifications and packaging considerations. We are well equipped to carry out the stability processes and the effective use of resources is covered through the planning of the stability program.

Innovation in packaging

Hologram does not only provide us brand security but also contributes towards Packaging Aesthetics, hence providing us better brand value. Packing designing is an art that requires a lot of knowledge about the latest market trends and acceptability. Our Quality Assurance Laboratory has a separate packing components section, which is responsible for components selection and testing its suitability according to the formulation of the drug.

JOURNEY TO OUR FACTORY

31Km Ferozepur Road, Lahore 

Factory Site: 

An all green beautifully landscaped area has been chosen for the factory site, a unique architecture design of the red bricks building, which gives an elegant look to the entire factory.

Head Office:

The first floor of the factory has been allocated for the head office, which is nicely furnished, producing an excellent working environment. All communication systems have been mechanized to create a quick flow of information.

MANUFACTURING ACTIVITIES

Our manufacturing plant has been designed according to the Drugs Act of Pakistan and GMP requirements. The new project consists of the following sections:

1- Ampoules / Vials Section
2- Liquid Section
3- Tablet Section
4- Cream / Ointment Section
5- Ophthalmic Drops Section
6- Anti-Biotic Oral Section
7- Anti-Biotic Sterile Section
8- Sterile Ampoules Section
9- Sterile Dry Vial Section
10- Cephalosporin Oral Section
11- Cephalosporin Sterile Section
And, Anti-Cancer Drugs

All these sections have been equipped with GMP certified machines, which produce high quality products. We have deputed well-trained staff to operate these sophisticated machines.

Solid Dosage Form:

A solid oral dosage form is easy to ingest and relatively more stable than the others. Almost two-third of our production falls in this presentation. The formulation of compressed solids involves highly intricate series of events, from the characterization of the active pharmaceutical ingredients, to the choice of recipients, to the selection of processing, compression, and coating equipment and packaging systems appropriate for the specific drug and the dosage form.

Our manufacturing facility meets all the GMP and regulatory requirements of manufacturing solid dosage whilst making sure of contents uniformity and avoiding any and all types of cross contamination. We meet all the pharmaceutical standards of disintegration and dissolution and our compressed solids are applied aqueous film coating. Accuracy of equipment is maintained to produce quality products. We have modernized our operations and have acquired the latest following equipment to produce solid dosage form:

1- Blenders
2- Ribbon Mixers
3- Tumbler 
4- High Shearing Mixer (at New Factory) 
5- Fluidized Bed Dryer Glatt Type (at New Factory) 
6- High Speed Rotary Compression Machine (at New Factory) 
7- Coating Pan 
8- Fully Automatic Coating System (at New Factory) 
9- Automatic Blister Packing Machine

In new products and in the case of change of source of active raw material, a stability test is carried out. We have all the facilities to carry out the stability of the products at different temperature. 

The tablets area is divided into four different sections, which are completely segregated to avoid cross contamination and to create the required environmental conditions of each section.

Dosage Liquid Products:

Liquid Products consist of Syrup, Suspension and Drops all of which are non-sterile. The consideration of prime importance for liquid drugs includes solubility of active drugs, preservation, taste masking, viscosity, flavoring, appearance and stability (Chemical, Physical and Microbiological), raw materials, equipment, the compounding procedures (often the order of mixing) and finally the packaging (to allow a stable product to reach patients).

Our main emphasis is on the stability of the drug in the liquid form (flavors and taste are also important). The provision of pure water is also a very important factor in our manufacturing process, which must be free from all contamination. Our manufacturing facilities use R/O Water and De-ionized Water for manufacturing.

Basic equipment is used for liquid preparations but they occupy large spaces such as Glucose Storage, Liquid Mixing and Liquid Storage Tanks, as well as Silverson, Syrup Filtration System, Liquid Transfer Pumps, Automatic Liquid Filling / Capping Machines, Bottle Blowing System, Filled Bottle Inspection System and Automatic Labeling Machines.

As per SOP's complete validation is carried out maintaining the following validation records:

1- Process Validation 
2- Cleaning Validation
3- Packaging Validation
4- Computer System Validation

DRY SUSPENSION / SYRUP / CAPSULES AND SACHETS:

These products have been classified in three categories:

1- Non-Antibiotic
2- Antibiotic (Penicillin Based)
3- Antibiotic (Non-Penicillin)

Each section has been completely segregated to avoid any cross contamination. Efficient Dust Extraction System has been installed in the sections where powder products are produced. Although all our formulations have simple processes and are easy to manufacture but the filling stage needs a lot of precaution and accuracy.

The following Hi-Tech machines are involved:

1- Semi-Automatic Powder Filler
2- Automatic Encapsulation Machine
3- Automatic Blister Packing Machine
4- Auto Labeler
5- Automatic Strip Packing Machine
6- Automatic Sachets Filler