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Infrastructure


 

Manufacturing Facilities

We have the following manufacturing facility at our Plant:

1. Tablets (Beta Lactum)
2. Tablets (Non Beta Lactum)
3. Oral Liquids
4. Ointments, Gels, Shampoo, Creams
5. Dry Syrups
6. Capsules


 

Ground Floor

The company’s Ground floor has the following :

1. Manufacturing Section- Oral Liquids
2. Manufacturing Section – Ointment
3. R.M. Store
4. Changing Room for Men/Women
5. Finish Good Store

 

 

Manufacturing Section- Oral Liquids:

The company posses the high and quality output machinery in oral liquid section

This section machinery includes Syrup Manufacturing Plant, Liquid Manufacturing Plant, and Storage Vessels. All three are Interconnected & Online. The machinery installed is all of Stainless steel 316 grades and are GMP Compliant.

For filling we have a single line six head high speed machine in manufacturing area. It has separate air handling system which disallows cross contamination of air. The area is furnished with flush doors, flush type fall ceiling and lighting fixtures, flooring with epoxy jointing. Water used is sourced through Double RO water system through SS316 piping GMP standards. In process quality control checks are documented and conducted during regular operations to meet the required quality standard. Men and Material flow directions as uniform flow. The manufacturing area is well lightened to ensure proper vision for smooth manufacturing process.

Deployment of Quality personnel for visual inspection to observe and discard any bottle with foreign/unwanted particle if any further attached to automatic Labeling machine for better labeling process, further attached to conveyor belt for final packing to cartons/Mono cartons.

Manufacturing Section – Ointment:

We have Semi automatic tube filling, sealing & crimping machine & also have equipment for 250 kg batch size. We have facility for filling and packing in both lami-tubes and aluminum tubes. The ointment section has separate AHU system with man & material flow is in uniform direction starting from materials receipt to finished product. The manufacturing area is well lightened to ensure proper vision for smooth manufacturing process. Regular monitoring by Quality assurance personnel to detect and discard any defective production.

 

 R.M. Section

1. The company holds a large space for storage of its Raw material designed as per strict compliance to Drugs & Cosmetics Act. The room is divided in to different sections with materials tested and untested stored with proper labeling. The Raw material room also has the independent AHU System which helps in maintaining desired temperature level in the section to maintain the potency of drugs.

The room has been divided as following:
Receiving Station: This area is meant for receiving and prior inspection of the incoming material.
RM Sampling & Dispensing Unit: This section is developed for sampling of incoming raw material & further dispensing of raw material to the production areas after testing.
Under Test Raw material store: Material is retained at this station till the quality analysis for RM is done.
Approved Section: The material is stored here after the final approval by Quality control department for the quality of RM.
Rejection Store: An area developed for the raw material which is found rejected by Q.C for not meeting up the quality levels.


Finish Good Storage
The company holds a large area for storage of its Finished Products. The room is well lightened and also has its independent AHU system to ensure desired temperature for better stability of products shelf life.

First Floor

The First Floor production area has the following:

1. Tablets (Non Beta Lactum)
2. Capsules (Non Beta Lactum)
3. Testing Laboratory

1. Tablet (Non Beta Lactum)

This section include variety of machineries all made up of stainless steel as per GMP compliance. The production area has the following machinery installed:
a. Fluid Bed Dryer
b. Rapid Mixer Granulator (Indo German)
c. Tray Dryer
d. Mixer
e. Octagonal Blender
f. Multi Mill
g. Compression machines
h. Compression Machine – D 27
i. Blister Machine (Shrine)
j. Alu Alu Pack Machine
k. Auto coater

The machinery installed in this section enables us to manufacture and supply any quantity of production requirement with quality. The entire machinery is PLC Based to ensure zero error operated by the skill professionals. The manufacturing area has separate AHU system, Dehumidifiers to achieve desirable environment. The machinery used during under processing of batched are properly labeled to ensure zero error & the machinery is thoroughly cleaned after finishing up of the manufacturing process. In process quality control checks are documented and conducted during regular operations to meet the required quality standard. Men and Material flow directions uniform flow. The manufacturing area is well lightened to ensure proper vision for smooth manufacturing process. Deployment of Quality assurance personnel to ensure quality manufacturing.



2.Capsule Section

This section include variety of machineries all made up of stainless steel as per GMP compliance. The production area has the following machinery installed:
a. Capsule Loader (Auto)
b. Capsule Filling machine (Auto)
c. Capsule Polish machine (Auto)
d. Capsule Inspection Machine (Auto)
e. Dehumidifier

The manufacturing area has its independent AHU system and dehumidifier system with temperature and humidity monitor helping in updating environment statistics. The machinery installed is PLC based to ensure zero error operated by skilled professional. The machinery used during under processing of batched are properly labeled to ensure zero error & the machinery is thoroughly cleaned after finishing up of the manufacturing process.

In process quality control checks are documented and conducted during regular operations to meet the required quality standard. Men and Material flow directions uniform flow. The manufacturing area is well lightened to ensure proper vision for smooth manufacturing process. Deployment of Quality assurance personnel to ensure quality manufacturing.

3. Testing Laboratory :

The section is divided in to:

1. Chemical Section
2. Instrument Section
3. Microbiological Section
4. Record Room
QC is responsible for the testing of the entire incoming, semi-finished and final product as per the laid down specification and its approval / rejection as per its status. The QC lab has the testing facility separately for instrumentation section, wet analysis section, stability and packing material testing and a separate microbiological testing area. The testing procedure and the sampling procedure are defined and narrated under SOP (Title: Sampling, testing and release of raw material), Sampling, testing and release of packing materials Sampling, testing and release of finished products. All the sampling, under test and approved activities are indicated by suitable color coded status labels. Different pharmacopoeial standards are followed as far as possible and further In-house specification is developed as applicable.

Specifications and standard testing procedures are prepared for the raw material,packing material, finished product and semi-finished product. Guidelines given as per various pharmacopoeias and other international regulatory requirements (WHO GMP, ICH,PICS) or the guidance in designing the specifications. The In-house test will be included as per the product requirements. In case of non-pharmacopoeial material, specifications and standard testing procedures will be prepared. The approved vendor, sampling quantity, sampling instructions, storage and sampling conditions of the corresponding product are mentioned as a part of the standard testing procedures. Quality control has to prepare the standard testing procedures, whose master copy will be archived at QA.Controlled copy of the standard testing procedures will be issued to the QC department through a document distribution record. Procedure for the generation, distribution and revision of QC specifications and standard testing procedure is narrated as per SOP .

Contract Analysis:

The company is having a well equipped laboratory for all chemical and microbiological analysis. If required some samples shall be sent for analysis to outside approved contract Laboratory. The contract laboratory is audited and compliances are seen as per the GLP requirements. Few of the laboratories whose services are being taken

1. Vatsa Testing Laboratories, Sonepat
2. Auriga Research Labs

SECOND FLOOR

The Second Floor production area has the following:
1. Tablets (Beta Lactum)
2. Dry Syrups

a. Tablets (Beta Lactum)

This section contains all the modern machinery viz RMG/FBD/Octagenaol blender made up of ss316 stainless stell as per the guidelines. The machinery installed in this section enables us to manufacture and supply any quantity of production requirement with quality. The entire machinery is PLC Based to ensure zero error operated by the skill professionals. The manufacturing area has separate AHU system, Dehumidifiers to achieve desirable environment. The machinery used during under processing of batched are properly labeled to ensure zero error & the machinery is thoroughly cleaned after finishing up of the manufacturing process. In process quality control checks are documented and conducted during regular operations to meet the required quality standard. Men and Material flow directions uniform flow. The manufacturing area is well lightened to ensure proper vision for manufacturing process. Deployment of Quality assurance personnel to ensure quality manufacturing.

b. Dry Syrups

This section consist of Automatic PLC based high output powder filling machine with automatic labeling . The section has dedicated AHU facility and Dehumidifer and also equipped with environmental monitoring system to remain updated to have the desired environment. In process quality control checks are documented and conducted during regular operations to meet the required quality standard. Men and Material flow directions uniform flow.

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