Pharma Plant Setup And Turn Key Project
CPPL is having expert engineers and Pharma Technocrats team for designing and commissioning of Pharma Plant Our GMP experts are well aware about requirements of Pharma Plant Setup and they always thing about clients cost saving while designing of Pharma Plant Logical and practical approach towards designing of plant is our specialty this saves clients time and cost With our designs approvals of FDA is also easy Our Engineers are trained in Pharma Sector so designing to commission is our responsibility.
Process Validation Service
Process Validation plays a important role in Pharmaceutical Manufacturing, manufacturers have efficient peoples and staff and efficient technocrats who can take care of Process validation activities but we observed that there are many Loopholes auditors or authorities are finding in process validation documents and which can not be corrected and it results into failure of audit.
CPPL has experts who designs process validation protocol according to need of your formulations and guides how to execute the same, also post completion of activity our team reviews entire document and provides suggestions or asks to correct the documents if anything goes wrong ,this saves time and this saves future issues in regulatory compliances.
What we can Do :
CPPL designs process validation protocol.
CPPL Gives sampling points and testing plan for execution of process validation.
CPPL team executes also entire process validation activities.
CPPL team compiles report and submit to the manufacturers.
CPPL team reviews report which manufacturer has prepared and suggest the changes according to need.
Standard Operating Procedure
SOP is heart of Quality system and well written SOP is always appreciated by Auditors and authorities. About contents Standard Operating Procedures there are many mis concepts in industry .
CPPL is always observing the changes but most of the changes are done only for satisfaction of managers and entire system gets collapsed because small but critical changes.
We are aware now everyone have Standard operating procedures but we also observed that 30 % procedures are made unnecessary to increase number of documents to show auditors ,this is real question whether these procedures are really useful, being followed or just hanged in factory to show the Auditors.
Another myth about Standard operating SOP is authority specific many times CPPL faces this issue that some manager is asking to change SOP saying that this SOP is not applicable or not being accepted by a particular Authority. We asks why? Standard Operating Procedures are not under purview of authority, it’s our own document , authority at the time of audit only looks what you have written is as per norms and are you following the same practice with documentary evidences.
Features of Our Service :
We have more than 1000 different Standard operating procedures written with us.
Perfect Customizable format with perfect Drafting of SOP.
CPPL Considered all GMP Norms and all kind of requirements while writing Standard Operation Procedures.
CPPL looks practical aspects while customizing standard operating Procedures.
The Formats and Standard Operating procedures are not at all overlapping or mixing with each other.
CPPL ensures that once Standard Operating procedures drafted for your company no need of changing this again and again for every Audit, Its Once for all.
Facility and Equipment Validation
Qualification of facility and Equipment is important part of any audit and its basics of Pharmaceutical Industry. Any validation which performed is always a permanent document and it needs to be perfect and error less so that at the time of audit it shall be presented perfectly and there shall not be any non-compliance.
CPPL Helps you in:
Designing Qualification protocols.
Assist in filling Qualification reports.
CPPL Executive are able to visit your site and execute entire qualification activity.
CPPL Provides protocol and reviews report of manufacturers.
CPPL helps in getting all certification from vendors.
CPPL helps in SAT, FAT Activities.
CPPL is having associated research Laboratories in India for formulation development and technology transfer, along with formulation sites we are also having analytical development facility with us. CPPL have more than 1000 products and formulations developed till now.
CPPL believes in technology which can be worked out and validated at client’s site. CPPL has technology transfer team with responsibility of successful validation of product at client’s site.
CPPL has expertise:
In development of new Formulation.
Has database which contains more than 5000 brands.
CPPL Provides complete analytical back up.
Cost effective solution providers from India.
Audits And Regulatory Compliance
Compliance Audit and Batch release Audit:
Many times it is difficult to assess compliance report and need arises for verification of compliance by third eyes. This is reason Pharma QA introduces Compliance verifications services before submitting the same to Regulatory Authority.
QP Audits :
Many Companies are following QP Audit procedures before releasing of consignments. We provide Qualified Pharmacists as QP for handling batch release and compliance activities on behalf of your company on Toll locations.
Example: If you are Nigerian Pharmaceuticals Company and manufacturing drugs in India this is not possible to monitor the manufacturing and product quality before dispatch from a long distance so we provides Qualified Pharmacists at your manufacturing Location who will take care of Quality of Product.
Process Audits :
Manufacturing process of Pharmaceutical Dosage forms if not performing desired quality and Output same shall be audited and rectified .This saves your cost as well as time. Many times as a routine practice your technical staff cannot do this as they are used to see the same on routine basis. Pharma QA Provides Experts who will evaluate your process and suggest the appropriate changes to achieve Quality of product and also Outputs.
Quality System Integration
There are many Approach towards Pharmaceutical Documentation and GMP Documentation:
1. Guideline Approach
2. Experience approach
3. Practical and productivity approach
These are approaches are changing manufacturer to manufacturer. At many places history of audit is considered for preparation of the audit and accordingly systems are being designed. Pharma QA has different approach. We observed that all the guidelines stated by various regulatory authorities are almost same only approach is auditors view and interpretation of guidelines .
Pharma QA interpreted guidelines on practical approach and designed a system which can be applicable to all regulatory guidelines of the world. Pharma QA believes that traceability and justification for every non compliance is most important so whatever Pharma QA designs it has traceability and it always gives very good compliance result.
QUALITY INTEGRATION SERVICE:
Pharma QA Provides Quality integration service which gives complete system implementation in Pharmaceuticals factories which will set a compliance for all regulatory guidelines of the world. A simplified GMP Documentation is heart of Pharma QA system development.
1. Pharma QA designs Quality management system.
2. Pharma QA Provides all documents and systems.
3. Pharma QA monitors all system.
4. Pharma QA Audits the systems.
5. Pharma QA Set a compliance for regulations.
Pharma QA Inspection Convention
CPPL introducing Pharma QA Inspection Convention Scheme for Pharmaceutical Manufacturers. CPPL has selected 30 auditors from different Parts of India and with different expertise areas. Under this Scheme we are requesting Manufacturers to certify their manufacturing unit from these expert Auditors and get a Grade to your unit.
Once you are applying we will send two auditors according to requirement and these Auditors audit your manufacturing site, system, manpower and machines and they will write their report based on this report we will certify your company and if require give some suggestions for improvement.
Gradation of the Plant will be as bellow:
Pharma QA refers well developed guideline of cGMP and evaluate your systems.
Pharma QA had prepared its own cGMP audit checklist which cover all major, critical and minor aspects of GMP norms of different countries, and hence after auditing your facility pharma QA corelate the compliance and non-compliance with different international regulations and prepares report which is clear about what regulations your plant is complying and at what shall be done to upgrade the plant with all GMP aspects.
On completion of audit pharma QA Provides:
1. Gradation to your facility.
2. A++ Complying to regulated countries like US, Europe, Brazil, Australia, other countries.
3. A+ Complying to semi regulated countries.
4. A Complying to ROW Markets.
5. B Complying to WHO norms.
6. C Complying to national regulations.
7. Pharma QA will issue a letter along with certificate and memento with specific recommendation. Pharma QA also recommends and give advise for up gradation of plant.
Pharma QA is known for it’s expertise and Skills for GMP Audit. Pharma QA Audits your facility and documentation with practical and highly regulatory views. Pharma QA Does Not miss even single point to evaluate. Pharma QA is having expert audit teams from All Sectors and segments.
1. Pre Audit for Regulatory
2. Vendor Audits
3. Contract Manufacturing Audits
4. Laboratory Audits
5. Internal Audits
6. Compliance Audits
7. QP Audits
8. Product Release Audits
9. Process Audits
Pre-audits for regulatory:
1. Pharm QA Offers Expert opinion and Evaluation of your facility and Documentation and let you know are you at what level as per as regulatory norms are considered.
2. This is necessary to get evaluated your factory with respect to GMP Norms of different authorities instead of blindly going ahead for any audit. Third person can find errors better way than a routine person as routine staff is used to all activities and errors.
3. Pharma QA Along with audits guide you through the approval and compliance process.
Benefits of Our Services:
1. Crystal clear Idea about grading of facility
2. Clear Idea about action plan for preparation of regulatory Audits.
3. Complete idea about Loopholes and GAPs of Quality System.
4. Can be used as a Improvement tools.
5. No need of keeping noncompliance tension as our executives and consultants are giving suggestions also
6. It Keeps your systems and factory updated
7. Management Gets right feedback about preparation
8. Training and other needs can be planned
Pharma QA have experienced GMP/GLP Trainers team to serve training needs of Pharmaceutical Manufacturer.
Features of Pharma QA Trainings:
1. Pharma QA Trains the Staff for basic GMP Concepts
2. Pharma QA Monitors evaluation and impact of Training
3. Pharma QA Trains the operators and other staff in vernacular language
4. QA Evaluate the training results and impact with written assessment
5. Pharma QA Usage audio visual methods for training
6. Pharma QA Provides Webinar
7. Pharma QA Organizes industrial seminars
|01||Basic GMP Training||Operators and Officers of the department|
|02||Advanced GMP Training||Staff, Executives and Managers|
|03||Quality System Management||Production And QA Staff|
|04||Trainers Training||All Managers and Trainers|
|05||Facing the Audits||All Managers|
|06||Discipline and Reporting habits||All managers and Supervisory staff|
|07||Technical Trainings||All staff|
|08||Validation Concept||QA,QC, Production staff|
|09||Good Distribution Practices||Stores|
|10||Sanitization and Hygienic practices||Housekeeping and Admin, QA|
3600 Documentation System
Till 2000 there was a approach of controlling documents by each departments of Pharma Industry But with changing scenario of the world quality system and harmonization of guidelines by many Drug regulatory authorities the things ahave changed a lot. Quality Assurance department has become center of complete industry and documentation system is heart of Quality management system
Pharma QA developed and Launched 3600 documentation system in many Pharmaceutical Units The developed documentation system is having many benefits with respect to traditional documentation system.
1. It’s having QA Control over the factory.
2. There is minimized level of manipulation.
3. Effective control over documentation.
4. Review system is stringent.
5. Archival and traceability is easy.
6. Online system and Online review is giving a assured compliance confidence.
7. Audits become easy.
8. Centralized documentation with issue and retrieval of documents it gives better compliance.
9. Reduces manpower and makes everyone accountable for their Job responsibilities.
World’s Pharmaceutical Industry is growing and with growth Quality Management systems are being Implemented by Pharma manufacturers and this becomes now necessary for Pharmaceutical manufacturers to have full proof traceable and auditable Quality Management system. ICH Q10 Guideline is also providing the similar approach.
Industry must improve quality systems with ICH Approach for betterment of Human being and animals. Medicine Cures but Medicine Also kills.
Pharma QA Quality management System:
1. Risk Based approach.
2. Integrated Quality management system.
3. Traceable and auditable GMP Quality management System.
4. Complete practical assistance while implementation Quality system.
5. Requirements and need based Quality management Solutions and advice.
6. Pharma QA Provides entire set of Documents ,Standard Operating procedures and Practical GMP Systems.
7. Pharma QA Customized Quality system approach is for compliance of Major regulatory Like UK MHRA,USFDA,EU,PIC/S,and many other countries of the world.
8. Pharma QA Also provide software Solutions for Pharma Industry to care of all audit points.
Why to Choose CPPL as your Regulatory and Dossier Partner
1. Knowledge of Pharmaceutical Technologies.
2. Knowledge about formulation and analytical techniques.
3. Minimizes time of registration with it's Perfect dossier service.
4. Complete Support for Generating documents like PV, AMV, Stability.
5. Comparatively very Low Cost (Do not compare with computer operators who provide Dossiers free of cost.
6. Honest services, we says yes if it is possible and no if having any difficulties.