Research And Development

We are a Delhi based, Fast Growing, Ethical manufacturing & marketing company having state of art, Ultramodern schedule M Compliance Plant at HARIDWAR in the vicinity of BHARAT HEAVY ELECTRICALS LIMITED, At  Sector-6B  of well deve­loped Integrated Industrial Estate of SIDCUL [State Industrial Development Corporation Of Uttrakhand Limited] in the state of Uttrakhand. The plant is only 10 km. away from Railway Station Haridwar and is well connected by road on Delhi-Haridwar National Highway No-58. The plant is situated on a peaceful area surrounded  by low height mountains on the southern side with two sides open to wide roads. No major polluting industry is located in  the vicinity of the company, there by offering a perfectly neat and clean dust free area suitable for manufacturing of pharmaceuticals.

The North and West sides of the plant are open to wide roads.  On the East side of  the plant is a Pharma Plant & on the South side Pharma  manufacturing plant (Akum  Drugs) . More over, the in side along with  boundaries have been beauti­fully landscaped with earth mounts and garden to provide suitable dust free atmosphere inside the plant as per GMP requirements.

As it is  important part for pharma industry to make the surrounding environment dust free, company took care  for it. All blocks and plant surroundings are covered by soft green garden plants, ornamen­tal plants . Inside the plant, all open area is also covered by, ornamental plants, which can fascinate anybody. This is being maintained regularly by well quali­fied horticulturists.

QUALITY MANAGEMENT SYSTEM
Quality is a relentless commitment at LMBL. Intrinsic quality in product is achieved and tested by adopting and consistently following the established procedures and norms which is  emphasized in the ‘quality policy.

There are separate Quality control and Quality Assurance Departments headed by competent, qualified and experienced personnel independent to the production. Quality Control Laboratory is divided into separate sections i.e. for Chemical, Microbiological and instrumental analysis; Stability samples and fully equipped with Latest Sophisticated instruments and experienced Analysts.

Quality Control  Department is effectively involved in the following activities :
         To sample, analyse and release or reject each batch of raw materials.

• To release or reject semi-finished product.
• To release or reject packaging and labeling materials and the final containers in which drugs are to be packed.
• To release or reject each batch of finished product that is ready for distribution.
• To evaluate the quality and stability of finished products, raw materials and semi-finished products.

The system of Quality assurance appropriate to the ‘Quality Policy’ and  manufacturing of pharmaceutical products is established and assured by effective in-process control and Monitoring procedures under the leadership of competent, qualified and experienced  Staff.

The Pharmaceutical products are manufactured, packed and tested in a way that takes account of the requirements of ‘Current Good Manufacturing Practices’ and ‘Good Laboratory Practices’.

Adequate controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out at regular intervals. Pharmacopoeias, reference standards, working standards, reference spectra, other reference Materials and technical books as required are available. The finished product is correctly processed and checked in accordance with established procedures as per WHO-GMP guidelines.
The robustness of the system is evaluated by conducting self inspection periodically by the competent, qualified and experienced team. The Pharmaceutical products are released for sale or supplied only after authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the label claim and any other provisions relevant to production, control and release of pharmaceutical products.

QUALITY POLICY:
“Quality is a Relentless Commitment at Life Medicare & Biotech Pvt. Ltd and Management is always desirous to provide the customer’s desired quality Medicines at competitive cost and maintain leadership in Health Care through continual improvement and Innovative technology”.

The firm has a robust quality management system that is effected through the following :

1. The Quality assurance department has developed exhaustive specifications for all input materials and finished products. These specifications are evaluated and updated and maintained by the QA department and are strictly followed.
2. Validated, approved and documented master formulae are available for finished products which form the basis for manufacturing and packing operations.
3. Products being manufactured are tested at various stages of manufacture as per the In Process Quality checks.
4. Each and every manufacturing step is documented in the Batch   Production Record of the product.
5. Analysis of all materials is done by validated, documented and updated standard Test procedures (STPs).
6. SOP (Standard Operating Procedures) are available for carrying out all operations. These include cleaning, calibration, maintenance and servicing of various Equipments, operation of various machines and instruments, receipt and storage of raw materials, packaging materials, sampling and release of various materials etc.
7. Validations protocol and procedures are available for validating equipments and Processes and Analytical Procedures.

AUDIT PROGRAMS

The facilities and system of the manufacturing site are frequently inspected by State Drugs Authorities and other Regulatory Agencies for the compliance.
Apart from this, regular self audits are carried out to evaluate the efficacy and robustness of the quality management system.

TECHNOLOGY
We are well known for our advanced technology known as “BIOREG” Technology. This technology is highly advanced over the conventional dosage form where frequent dosing is required for a patient. In  cases of some drugs this technology not only reduces the chances of forgetting doses but even reduces the quantity of dose.

What is BIOREG Technology ?
 It is a Unique Drug Delivery Technology which undergoes various technical procedure & processes .

1. The Bio reg technology is a special technology developed by Life Medicare & Biotech.
2. By virtue of the Bioreg technology , the release pattern of the drug is independent of PH as well as the food intake.
3. The technology offers the uniform dispersion of the microfined particles thus offering greater absorption area pertaining to increased bioavailability.

Most importantly from the manufacturing as well as the clinical point of view , BIO REG CR system tablets has many inherent advantages:

1. Material used in the tablets is approved world wide.
2. Confer high degree of stability on the finished products.
3. The released characterstics are independent of the compression pressure used during manufacturing.
4. The relative insensitivity of this preparation to punch pressure.

BIO REG TECHNOLOGY is undoubtfully a superior drug release pattern as  the technology promises to take care of all the three aspects i.e:

1. Dissolution
2. Dispersion
3. Diffusion

Rationale behind BIOREG TECHNOLOGY:

1. High flexibility in choice of release rates.
2. BIOREG system is applicable to broad range of drugs.
3. High loading of active substance .
4. Offer excellent patient Acceptance
5. Scored tablets.
6. High reproducibility of the release rates