Raw material testing, packing material testing, in process testing, microbiological and finished product testing will be done at all the stages of manufacturing.
To maintain high standards in the quality , our manufacturing facilities are equipped with advanced instruments like HPLC(Gradient), G.C, UV-VIS, Potentiometer, Karl Fisher, Melting Point Apparatus etc.Which helps us to deliver the quality products.
Quality Control Department Comprises of
- Central Quality Control Laboratories with instruments, chemicals, in process quality control, microbiological facility
- Documentation
- Control samples & Stability
- Validation
- Audits
- Investigation
- Reserve Sample Management
Quality Assurance:
SKHC quality focus encompasses all areas of operation - from procurement of the best raw materials to optimum manufacturing technology, to precise delivery of the customer's requirements - thus ensuring a rapid penetration of both domestic and global markets.
The industry leader position SKHC enjoys today has largely been achieved through its delivery of unsurpassed levels of quality.
There is regular validation of processes, test methods, water and environment, as well as periodic calibration of all instruments, to guarantee product output of consistent top quality. Vendor evaluation and selection is carried out as per stringent quality, product, manufacturing, service and delivery parameters to ensure the highest quality raw materials.
The Quality Assurance Department, manned by qualified personnel, constantly monitors quality parameters - performing systematic sampling and testing at every stage from raw materials, through each process of intermediate and finished products.
A full fledged Quality Control Laboratory which follows Good Laboratory Practices and incorporates the most modern testing equipment, in order to perform the stringent quality analytical tests prescribed by different Pharmacopoeia.
Microbiology & Sterility Laboratories are provided with Class 10000 Cleanliness and a SS horizontal Laminar Air Flow Unit. The full spectrum of microbiological and sterility validation tests are conducted for on-going constant microbiological monitoring of all processes and products, as well as personnel and production areas, to ensure total product purity.
Documentation and Record System:
Each batch processed under controlled series of in process checks which are recorded in batch production record. On completion of any batch the samples are checked by quality control labs & released for finished goods transfer. All necessary details are recorded in batch production record. This batch is transferred to finished goods godown for further distribution.
The SKHC quality value is defined as
Since its interception SKHC has been synonymous with the belief and reliability inherent in the word Quality. Quality is rooted in the work of our personnel’s and all our values. We are devoted to the delivery of quality healthcare around the world. Our business practices and processes are projected to achieve quality results that exceed the expectations of the customers, colleagues, business partners and regulators. We have an uncompromising passion for Quality in everything we do.
The Quality Value is standard against which we measure ourselves and a guide for the decision making in any indefinite situations. We dedicate ourselves to providing the highest quality pharmaceutical formulation products to our customers. At the same time, we focus our energy on the quality of health and healthcare around the world
SKHC is committed to research as a means of developing innovative and effective medicines. Research drives the company's plans to become an international pharma company. A focused effort in well-defined areas and an abiding interest in new technology are key features of research efforts.
The approach has been incremental: from simpler dosage forms to novel drug delivery systems. The highest priority area is new chemical entities / novel drug delivery systems.
Regulatory Affairs:
SKHC is having a team to full fill the requirement of documentation to register the products as per different Ministry of Health’s (MOH’s) to meet the customer needs from different regions like south East Asia, South Africa, Europe, & US. Regulatory Affairs department team is highly qualified & experienced in registration of pharmaceutical Formulations products as per the guidelines.
Regulatory department co-ordinate with the Business Development Department (BDD) to research the market for new chemical entities to launch products as per the guidelines.
Regulatory department continuously audits the manufacturing sites to implement the new guidelines as per the different regions of countries.
RA prepares the dossiers as per the Common Technical Document (CTD) format for universal acceptance for better review the product document.
Having its manufacturing base in India makes the company even more competitive in international market. The company's core activity is conditioning of Medicines for human use in various forms, it has also excel in formulation of Natural Hygiene products and Nutraceuticals. To comply with the changing demand and expectation of our customers, we offer a wide range of products for human use covering almost all therapeutic groups.
The name of the company encapsulates its being. The company reflects very highly on professionalism. It is its professional culture, which has helped it to lay a rock solid foundation and build a huge reputation.
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