Manufacturing & Quality
WHO-GMP and ISO certified manufacturing at SIDCUL, Haridwar.
Our infrastructure
The organization is backed by modern formulation manufacturing facilities with fully automatic online operation. The organization has a wide range of products in pharmaceutical dosage forms such as capsules, tablets and syrups. These products are manufactured under strict GMP guidelines to produce quality products within the specified time frame. Apart from this, we have a warehouse that offers safe storage.
Moreover, to ensure a longer storage life, these products are packaged effectively using good quality raw material. We regularly upgrade our facilities, not only in quality but also in terms of proper management and administration.
Warehousing & packaging
Our organization has developed a spacious and effective warehouse, equipped with modern facilities, for storing our products until they are ready to be dispatched. Being sensitive and chemically active, these products need very safe storage. Features of our warehouse:
- Very spacious
- Properly segregated
- Isolated from any moisture
- Temperature resistant
Packaging
We also offer reliable packaging solutions to our clients. As our products are sensitive in nature, safe and proper packaging is required. Features of our packaging:
- Moisture resistant
- Temperature resistant
- Air tight
- Made with high-grade packaging material
Quality assurance
Being a quality-focused company, we have achieved a strong position in the industry by offering a range of top-notch quality pharmaceutical products that are effective, consistent in composition and stable, with a long shelf life. Customers value our quality-driven approach, which sets us apart from our competitors.
QA is responsible for
- Maintaining GMP at all stages of production and control
- Review of production records
- Review of product specifications and test procedures
- Release of finished goods
- Quality audits
- Stability studies
- Vendor validations
- Product complaints and recall
- Validation and qualification
- Calibration and verification
- Self-inspection
- Develop/issue/review all protocols jointly with the user department
- Review of all material documents and SOPs
Elements of the QA system
- Specification and clearly written job responsibility for each employee
- Specified and clearly written standard operating procedures and work instructions
- Validated processing procedures
- Specifications of raw material, packing material, work in progress and finished goods
- Validated analytical methods
- Data collection and statistical evaluation of quality
- Vendor audits
- A complete validation master plan
- A well-designed complaint handling and product recall system
Self-inspection
A self-inspection team comprising the Production Manager, Quality Assurance Manager, Quality Control Manager and Maintenance Manager conducts internal audits periodically as per an established plan. An inspection report is prepared after the inspection of facilities and systems. The report is circulated to the people concerned with an action plan and a target date for completion. External audits are also carried out by various agencies from time to time, and compliance with any points raised is documented.
Review of results
The efficacy, safety and quality of the product are ensured through a series of validations carried out during manufacture and analysis. Each production batch is reviewed by QA for completeness of manufacturing, analysis, packing, IPQC, yields and deviations prior to the release of the batch.
Assessment of suppliers
The company maintains its own vendor audit and appraisal system to evaluate suppliers.
Vendor approval
A complete vendor validation plan covers suppliers of critical starting materials and packing materials, which are assessed by routine audits or questionnaires.
Release procedure (finished products)
Products are analysed as per laid-down specifications. Products that meet the specification are released as APPROVED and may be dispatched. Any product not meeting specifications may be retested as per the SOP for OOS and is REJECTED if it does not comply.
Product recalls
The Quality Assurance department decides whether a recall is necessary and defines the class of recall.
Client satisfaction
We are a client-oriented organization. Our products undergo several tests to ensure their safe usage standards before dispatch. Our manufacturing process adheres to GMP norms to ensure optimum quality. To provide a longer storage life and to protect our drugs from moisture and heat, they are carefully packaged before dispatch.
Quality policy
Our mission is to improve lives through continuous innovation by providing high quality pharmaceutical and healthcare products and services, while achieving customer satisfaction, enhancing employee development and stakeholders’ returns.
Testing in our laboratories
Physicochemical tests
- Description
- Solubility
- Identification
- pH
- Ultraviolet spectroscopy
- Infrared spectroscopy
- Uniformity of dosage forms
- Average fill
- Particulate matter
- Equipment cleanliness monitoring
- High Performance Liquid Chromatography
- Gas Chromatography
Microbiological tests
- Sterility test
- Pyrogen test
- Bioburden
- Antibiotic susceptibility
- Water testing
- Sterile area monitoring
- Microbiological assay of drugs
- Bacterial endotoxins test
Other tests
- Testing of containers (vials/ampoules), rubber plugs and aluminium seals
- Testing of packing material
Manufacture with Elfin
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