Services

CPC reviews the existing Quality System and helps in up-gradation of the same. It assists in the review/ preparations of :

• Site Master File 
• APQR
• Standard Operating
• Procedures like:

1. SOP on SOP
2. Document and  data control. 
3. Deviations Management
4. Investigation into OOS results.
5. Incidence management
6.  Investigation into market complaints
7.  Product recall or return   
8.  Change Management 
9. Quality Risk Management

• Raw data Management
• Data Integrity
• Reference standard management
• Stability 
•  Internal Quality Audits
• Validations – process, cleaning, equipment, utilities, method validation, 
• Qualifications
• Technology transfer / method transfer
• Calibrations
• Trainings  etc.

• The preparation / review of DRUG MASTER FILES –    USFDA, EDQM, EU GMP etc in CTD format.
• Module 1 (Administrative & prescribing region specific information)
• Module 2 (Quality Overall Summary)
• Module 3 (Quality)
• Preparation, review and filing changes to the registered documents.  

CPC helps in the preparation of following types of DMFs as per FDA guidelines.

• Type II : Drug Substance, Drug Substance Intermediate, and Material Used in the Preparation of Drug Product                         
• Type III : Packaging Material
• Type IV: Excipient, Colorant, Flavor etc.                                                     

Compilation of Open and Closed parts of DMF.              

CPC has expertise to convert the

DMF into eCTD DMF.

Addressing DMF deficiencies or reply to the assessor’s queries

Be it a small / start up company or an established company, Inspection can turn disaster if not handled well.

CPC  helps you in turning an Inspection into a great business opportunity and make a long lasting impression on the regulatory body. Its services include:

• Pre -approval audit / GAP analysis.
• Addressing the deficiencies found during pre-approval audits / GAP analysis.
• Trainings.
• Preparing the site to face inspection. 
• Participating in inspection as observer.
• Helping the company to address audit observations.

If there are any 483 observations or audit observations CPC closely work with the  Company to address the same. It also helps Company to give reply to Warning Letter, review of the documentation and submission to FDA.                                                                

Since its inception CPC has assisted in 135 successful International Inspections.                      

Started in 2004. 

The first a Green Field Project - Titan Laboratories, Mahad, Maharashtra for making modified release drug Delivery Systems. It has been approved by EU GMP, Korean FDA, TGA Australia etc. Following this CPC have under taken several Green Field and Up-gradation Projects - API’s & FORMULATIONS.

The project division 's services include:

• Conceptual designing and Master Plans
• Architectural and Interior designing
• Civil, Mechanical & Electrical.
• Piping & Utilities - HVAC
• Effluent & Water Treatment
• Project Management
• Documentation and Regulatory compliance

CPC  imparts various training programs on GMP to meet Quality and Regulatory requirements. Its personnel regularly attend training programs organized ECA in ICH Q7 GMP guidelines and Auditor Training course as well as advanced  GMP Topics like

• GMP/cGMP
• GLP
• GDP
• Risk  management
• Failure investigations
• Quality by Design
• Data integrity
• Computer system validation
• Qualifications, process & transport validations
• Elemental & Genotoxic Impurities
• Audit trail review

CPC PROVIDES FOUR EFFECTIVE PACKAGES FOR CONTROL OF DATA INTEGRITY RISKS 

PACKAGE-1

GAP ANALYSIS

SOP PREPARATION

PACKAGE-2

SOFTWARES 

COMPUTER SYSTEM VALIDATION

PACKAGE-3

DATA INTEGRITY 

POLICIES PREPARATION

TRAINING ON DATA INTEGRITY AND ETHICS

PACKAGE-4

RETROSPECTIVE DATA VERIFICATION OF ELECTRONIC RECORDS AND PAPER 

We have necessary expertise for carrying out 3rd party audits on your behalf to ensure that the auditee remain in state of compliance. 

CPC  has APIC certified auditors. 

Benefits of Virtual Audits

• Time and cost efficient
• Avoids Travelling to different location.
• No need of audit logistics.
• More efficient team

CPC has strong relationship with a number of Indian companies and can act as an interface between the Foreign and Indian companies in identifying the right partner, products and technology.

CPC can also provide end to end marketing services to Indian companies looking to sell their products/APIs abroad.