Quality manual
The Quality Manual demonstrates and documents Lipomic Healthcare’s commitment to maintaining a high-level of quality and strong customer service within an environment that has product quality and product safety as a first priority.
The manual is divided into sections, and correlates to the Quality Management System sections of ISO 9001:2008. It provides an overview of the quality policies and key requirements for Lipomic Healthcare. It is the source of reference for all matters dealing with quality.
This manual is used internally to guide the company’s employees through the various requirements that must be met and maintained in order to ensure customer satisfaction, product quality and continuous improvement.
The manual is used externally to introduce the Quality Management System to customers, third party quality auditors, authorities and other external organizations.
Statutory requirements and regulations
The quality system described in this Quality Manual shall ensure that Lipomic Healthcare complies with the following laws, regulations and guidelines:
- 21 CFR Part111
- GOEDomega-3
Services Offered
Lipomic Healthcare was established in 2013. The Company business activities are based on The Omega Boost Health Concept that restore normal balance between the essential fatty acids Omega-6 and Omega-3 in whole blood within 120 days. All productions and storage are outsourced. Products are sold through distributors. Analytical quality control is conducted in cooperation with Arjuna. Research, product development, quality assurance, economy control, invoicing and customer contact are conducted by internal resources.
Organization
The employees hold more than % of the shares in the company.
Purpose
The purpose of this Quality Manual is to establish and state the general policies governing Lipomic Healthcare’s Quality Management System. These policies define management’s intentional provision for managing the operations and activities in accordance with the current GMP-guidelines. These are the top-level polices representing the company’s plans or protocols for achieving quality products and customer satisfaction. All written procedures must conform and parallel these policies.
General information
Lipomic Healthcare Pvt Ltd. is registered in Pune, India under the companies Act, 1956. Address: 3456, New Delhi 110008, India
Quality policy
In order for Lipomic Healthcare to achieve a position in providing high quality products, Lipomic Healthcare shall develop and implement a Quality Management System fully compliant with the requirements of current Good Manufacturing Practise (cGMP) for dietary supplements. This will result in the overall product improvement over time.
Lipomic Healthcare shall be working for increased satisfaction of all interested parties, including customers, personnel, suppliers, authorities and owners, by establishing their needs and expectations and by acting in a balanced way for fulfilling them.
We shall:
- Sub-contract the manufacturing only to companies with a well-established quality system.
- Only use high quality raw materials which are traceable to the original manufacturer.
- Develop good relations to suppliers ensuring that the services do not compromise Lipomic Healthcare’s requirements and expectations.
- Ensure the protection of all customer’s confidential information and proprietary rights.
- Avoid involvement in any activities that would diminish confidence in our competence, impartiality, judgment or operational integrity.
- Ensure that management and other personnel are free from any undue internal and external commercial, financial and other pressures that may adversely affect the quality of the work. This is achieved by sub-contracting the quality control to independent 3. parties.
- Have adequately educated and trained staffed.
- Ensure compliance with all statutory requirements and regulations applicable to Lipomic Healthcare’s organization or the provided services.
Continually improve the effectiveness of the quality management system by periodical review.
Scope
To meet the objectives defined in the quality policy, Lipomic Healthcare has implemented a Quality Management System in compliance with cGMP for dietary supplements. The Quality management System is described in this quality manual and in a number of SOPs.
The Quality Management System shall thus ensure that the company meets the quality requirements set by customers, authorities and own routines, and enable further development of the company’s quality level. The Quality Management System and the implemented routines ensure a high product quality.
Quality Management System
Lipomic Healthcare has defined and documented quality procedures consistent with the requirements of the standard. The quality procedures further describe criteria, methods, detail activities, responsibilities and the quality assurance measures that are required to ensure effective operation, high product quality and control of the business processes. The Quality Management System also includes other documents and records required by the organization to ensure effective operation and control of the product. The Quality Management System at Lipomic Healthcare
- Is documented
- Is regularly reviewed
- Describes all critical processes and activities
The management is actively participating in the Quality Management System. The Managing director has appointed a QA manager with responsibility and authority as described in the designation of occupation and in detailed in the job description.
The Quality Management System consists of independent systems which also describes processes and monitor the effectiveness:
- Organization, incl. job description
- Documentation
- Production and process control
- Deviation, complaints
- Sub-contractors
Inputs to the continuous improvement of the Quality Management System are:
- Customer requirements
- Authority inspections
- Customer complaints
- Internal requirements
Responsibility and authority in the organisation is defined and communicated by:
- Organization chart
- Routines in the quality manual and in SOPs
- Job descriptions
Customer focus
Lipomic Healthcare strives to identify current and future customer needs, to meet customer requirements and exceed customer expectations.
The management ensures focus to be on improving customer satisfaction is maintained by setting and reviewing objectives related to customer satisfaction at management review meetings. The specific needs of our customers are determined through continual verbal and written communications.
Production and service provision
Risk management (e.g. HACCP) is an integrated part of the Quality Management System. This implies identification and assessment of microbial, chemical or body hazards and its risks during manufacturing, distribution and use of a particular product, including definition of a means for their Control.
Lipomic Healthcare manufactures the products solely by using pre-approved sub-contractors. Lipomic Healthcare maintains a record for each batch of product that provides traceability and identifies the amount manufactured and released for distribution.
Certificate of analysis is received from the product manufacturer, and samples are sent to an independent 3. party laboratory for analysis. A final batch certification is performed by Lipomic Healthcare upon release for distribution based on documents from the sub-contractors and independent 3. party laboratory analysis.
