Introduction

Aptly Pharmaceuticals
Passion to lead
Power to heal
1.1. Brief Introduction to the Company:
Aptly Pharmaceuticals is a veterinary pharmaceutical company which is established
with foremost emphasis on provision of quality products for improvement of poultry and
livestock health. It is the result of unrestrained efforts of Dr. Ahsan Akhtar, a man with passion
for excellence and desire to make a difference.

We see Aptly Pharmaceuticals as a professionally managed, rapidly growing

pharmaceutical organization, focusing on quality, value, service to customers and consumers
through optimal utilization of resources. Our core value is commitment, team work & business
orientation.

Mission

Our mission is to set our standards of innovation, excellence and commitment in highly competitive
market by providing high quality and cost effective veterinary medicines.

Vision

Our vision is to distinguish APTLY Pharmaceuticals as dedicated & leading symbol of veterinary
pharmaceutical products in National & International market by maintaining high quality standards
and products.

1.2. General Information:

Name & Address Responsibility

Aptly Pharmaceuticals
Manufacturing, Packing, Labeling,
05 Km, Sargodha-Sidhar Bypass Road, Testing, Storage & Distribution
Faisalabad.
1.3. Valid Manufacturing License No. 000887 for following section;
 General
 Oral Liquid
 Oral Powder
 Antibiotics
 Oral Liquid
 Oral Powder
 Penicillin
 Oral Powder

1.4. Name: Aptly Pharmaceuticals

Telephone No.: +92 41 2633200

Fax No.: +92 41 2633200

Registered Office & factory: 05 Km, Sargodha-Sidhar Bypass road, Faisalabad.

E-mail: aptlypharma04@gmail.com

Product line

1.5. Types of Products:

 General
 Oral Liquid
 Oral Powder
 Antibiotics
 Oral Liquids
 Oral Powder
 Penicillin
 Oral Powder
Location

Nature of Construction and Finishes:

Brief description of construction is as follows;

Walls : Concrete well painted with no dust retaining site.

Floor : Concrete with molded corner.

Ceilings : Plaster of Paris painted ceiling with molded corner.

Doors & Windows : Aluminum and Transparent Glass.

Lighting : Conceal LED lights with paper covering.

Piping & drainage : S.S pipes for supply of Purified water from water
treatment plant to different areas in Production and other
Premises.

S.S P Traps.

1.6. Brief Description of Ventilation system:

 The facility has been provided with proper HVAC system installed by MW
ENGINEERING WORKS with capacity 80.19 tons for air filtration, temperature, humidity
& differential air pressure control.
 Split Air conditioners are also installed for temperature control with capacity of 28 tons.
The detail of HVAC system of Aptly Pharmaceuticals is given in Annexure-I and layout is
attached herewith.

1.7. Brief Description of Water Purification System:

Source of raw water : In-house 90 feet deep tube well

Purification of Water : By Double Reverse Osmosis-Deionization Unit

(By SHAFFAF TECHNOLOGIES)

Capacity : 1000 Liters / Hr

Make & Origin : Hydranautics USA (SHAFFAF Self-imported)

(RO Membrane)
1.8. Cleaning & Sanitation
 Cleaning and sanitation of premises is conducted by housekeeping department as
prescribed in respective SOPs and is checked by concerned area supervisor and counter
checked by the QA department.
Quality Management System:
We have integrated our quality systems in line with the requirements of cGMP standards,
and are intended to carry on a process-oriented approach to quality systems in order to satisfy
current and emerging customer needs, consistently.

Achievement of quality is the prime responsibility of all the functional heads. They are
responsible for ensuring that the systems run as per the procedures listed out in manual of the
Quality Management System. They are also accountable for deviations of any form.

Our main objective is to develop a production-centric, GMP-compliant, ‘zero-defect’

system that allows for continuous improvement in the long run.

Our Quality Management System hierarchy is;

CEO

Managing
Director

Director
Operations

Production QC QA
Manager Manager Manager

Technical Team
Warehouse
In-charge
Organizational Chart

CEO

Managing
Director

Director
Operations

Assistant
Production
Director QC Manager QA Manager
Manager
Operations

Admin Warehouse
Manager In-charge

Technical Team
Accounts
HR Manager
Manager

Admin
 PRODUCTION
Aoromox C-23 Powder

Each 100 gm contains

Amoxicillin trihydrate …………………………... 23.00 gm

Colistin Sulphate ……………………………..… 100 MIU

 The general method of manufacturing of Aoromox C-23 is explained with the help of flow chart.
 Steps prior to manufacturing are discussed here briefly.
 First of all raw material is received in Raw Material Quarantine.
 Sampling of the material is done and sent to Quality Control Department for testing.
 If the material meets the limits of SOPs then it is passed otherwise it is rejected and sent back to
supplier.
 In case of approved or passed raw material, it is shifted to the green racks of raw material store.
 The Production department forwards the requisition for material dispensing for the specified
batch to be manufactured.
 This requisition is issued by Quality Assurance department and received by production
department for further working.
Following is the flow chart of general working for the manufacturing of powder.

ORAL POWDER (PENICILLIN) FLOW CHART

QC Approved Raw Material

QA Check

Issued for Production

QA Check

Drying (if required)

Sieving
QA Check

Mixing

If does not comply QC Check If complies

Rejected/Reworked
Released for filling
QA Check

Filling

Packing QA Check

Q.C. Check

If does not comply If complies

Rejected or reworked Transfer to FGS

= Line Clearance

QA Representative is present at every step of production

 Issues involved during the design of Product:
 The major concern during designing of product is to make sure that the product formulation is
stable over the stated period of stability.
 Accelerated stability studies are carried out before marketing of the product.
 Samples from the first/pilot batch are retained for real time stability studies also.
 The choice of packing material is also important that it should be inert.
 Packing material e.g; jar, caps, seals, alu-foil, polythene bags should be non-reactive with the
product.
 Outer packaging is designed observing the standards and requirements of the DRAP.

Issues involved in formulation of Product:

 Several issued are involved which can be avoided by taking precautions during manufacturing of
a product.
 First of all safety issues, the personnel are trained to operate the machinery safely and to remain
vigilant during working of machines.
 Spillage of material is avoided by transferring the dispensed material in closed cabinet trolleys.
 Leakage of jars, bottles, polybags and seals is checked before starting the process of filling and
packing.
 Temperature and humidity plays a major role during processing of powders.
 HVAC is checked on regular basis to make sure that the temperature and humidity are
maintained and HVAC is working properly.
 Quality Assurance officers are present at each step to make sure that there should be no issue and
working must remain streamlined.

Life cycle of Product:

 The life cycle is usually 2years from the date of manufacture of a product.
 This claims that the product will be stable over the accelerated conditions of temperature or
humidity.
 By the word stable we mean the color, odor, appearance of product will remain the same as that
at the time of manufacturing and packing.
 Samples of each batch of product which is being marketed are retained in quality control lab. For
regular stability studies and data is recorded by the quality control officer under the supervision
of seniors.

Technology used in process:

 All the equipments used for the processing of products are in accordance with the requirements
of DRAP.
 Latest laboratory equipments are used for the testing of raw materials, in-process samples and
finished products.
Factory layout