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CALGS makes all efforts in providing guidance to clients on a broad range of regulatory and technical issues. Since our team has access to a vast range of companies and is also faculty at training courses organized nation wide, their level of exposure is very high as compared to in-house personnel and hence, our clients have access to a deeper level of expertise. We support clients requiring a particular type of expertise or service for a required period of time, thus providing them with a cost-effective solution. As a matter of fact, we assist organization to develop a new strategy or solve a particular problem and hence, act as a facilitator.
Hiring a consultant as a check for overall working and improvement of a system is generally considered good corporate governance.
The scopes of service provided by us vary from simple training to turn key projects, including international approvals. Some of the services are listed below:
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| NEW MANUFACTURING FACILITY |
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CALGS provides support on setting up of a new pharmaceutical or medical device manufacturing facility. Our support covers Design, Construction, Adaptation of building, HVAC System, Documentation, Training, Validation and Qualification; Approvals by the National and International regulatory agencies. |
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| EXISTING PREMISES: EXTENSION, MODIFICATION |
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Organizations facing a problem in complying with revised Schedule M or looking for expansion may seek our support. We provide them with a revised building layout and HVAC system as per guidelines. Cost effective solutions are provided in respect of Building & Documentation. Internal Audit, Qualification and Validation activities are also undertaken simultaneously. |
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| TURN KEY PROJECTS |
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CALGS also offers consultancy for projects on turn key basis. The technical support covers aspects of Land Selection, Estimates, Building Designing; Selection for Contractors for Civil work, Air Handling Systems, Electrical and Plumbing Work, Supervision of Construction, Equipment Selection; Validation and Qualification; Selection of Personnel and their training; Documentation; Initiation and Operation of plant; Certification for GMP/ISO 9001/CE and other international approvals. |
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| IN-PLANT TRAINING |
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Training of employees as per organization’s convenience has been made easy by offering in-plant training courses. These courses can vary from a single day course to an intensive 3 day one. The course outline is decided on the basis of needs of the organization. Client-site personnel learn through comparison of what exists in their plant and what is required. The courses are tailored for every level starting from workers to senior management. To name a few:
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| INTERNAL AUDIT |
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An audit is a documented activity performed in accordance with written procedures or checklist to verify, by examination and evaluation of objective evidence, that applicable elements of the quality assurance programme have been developed, documented and effectively implemented in accordance with specified requirements.
CALGS provides support in organizing and carrying out internal audit. Trace forward, Trace Backward and Random Approaches are used to help client in development of Audit Programme, Conduct Audit and Report Writing. The client is also trained on setting up regular audit process.
We conduct internal audit about a month in advance to external audit to identify deficiencies in observance of requirements and thus helps companies to take corrective actions and confidently face the external audit. |
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| AUDIT OUTSOURCING |
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Due to limited man power, at times companies are not able to effectively conduct audit of their vendors/suppliers. CALGS offers audit support to companies who would like to outsource this task. |
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| DOCUMENTATION |
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Documentation is an essential part of Quality Assurance and hence shall cover all aspects of GMP. Good documentation helps in operation of plant smoothly.
CALGS provides support in developing complete documentation such as Quality Policy, Quality Manual & Objectives, Site Master File, Procedures, Specifications, Drugs Master File, SOPs, STPs, Guidelines, Environment Monitoring, Drawings, Flow Charts, BMRs, Formats & Data Sheets. Documentation also includes Document Distribution & Control, Review System, Change Control System, Recall, Complaint Handling, Non-Compliance & Non-Conformities. The employees are guided to prepare documents on their own. |
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