QA Agreement Revised2
21
Quality Agreement between Bayer Philippines, Inc. and Quality Agreement This AGREEMENT, made and entered into this ________________, 2011 at Canlubang Industrial Estate, Calamba, Laguna, Philippines by and between: BAYER PHILIPPINES, INC. a corporation duly organized and existing by virtue of the laws of the Republic of the Philippines with principal office address located at Bayer House, Canlubang Industrial Estate, Calamba City, Laguna 4028, Philippines and herein represented by its General Manager-Animal Health Division, Mr. Andrew Mantek, and Ms. Cynthia Miravite, QA & QC Officer and hereinafter referred to as “BAYER PHILIPPINES, INC.”; -and- Inphilco, Inc ., a corporation duly organized and existing by virtue of the laws of the Philippines_________ with principal office address located at 7 th Floor Ave Maria Bldg. 1517 Quezon Ave. , Quezon City ________ and herein represented by its ________ , ________________________ and hereinafter referred to as “______________ ”; together referred to as the PARTIES. Witnesseth that : Preliminary Remarks In the Pharmaceutical industry, contract manufacturing means the production, processing, packaging and quality control of materials or pharmaceuticals with a division of responsibilities. WHEREAS , the purpose of this Agreement is to define and establish the obligations and responsibilities of BAYER PHILIPPINES, INC. and Inphilco, Inc._ relating to the Quality requirements of the PRODUCTS manufactured by Finnfeeds Finland Oy and supplied to BAYER PHILIPPINES, INC. in accordance with cGMPs. 1
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Transcript of QA Agreement Revised2
Quality Agreement between Bayer Philippines, Inc. and
Quality Agreement
This AGREEMENT, made and entered into this ________________, 2011 at Canlubang Industrial Estate, Calamba, Laguna, Philippines by and between:
BAYER PHILIPPINES, INC. a corporation duly organized and existing by virtue of the laws of the Republic of the Philippines with principal office address located at Bayer House, Canlubang Industrial Estate, Calamba City, Laguna 4028, Philippines and herein represented by its General Manager-Animal Health Division, Mr. Andrew Mantek, and Ms. Cynthia Miravite, QA & QC Officer and hereinafter referred to as “BAYER PHILIPPINES, INC.”;
-and-
Inphilco, Inc ., a corporation duly organized and existing by virtue of the laws of the Philippines_________ with principal office address located at 7 th Floor Ave Maria Bldg. 1517 Quezon Ave. , Quezon City________ and herein represented by its ________ , ________________________ and hereinafter referred to as “______________ ”; together referred to as the PARTIES.
Witnesseth that :
Preliminary Remarks
In the Pharmaceutical industry, contract manufacturing means the production, processing, packaging and quality control of materials or pharmaceuticals with a division of responsibilities. WHEREAS , the purpose of this Agreement is to define and establish the obligations and responsibilities of BAYER PHILIPPINES, INC. and Inphilco, Inc._ relating to the Quality requirements of the PRODUCTS manufactured by Finnfeeds Finland Oy and supplied to BAYER PHILIPPINES, INC. in accordance with cGMPs.
WHEREAS , Finnfeeds Finland Oy manufactures, processes, packages and tests the products on its own responsibility, in accordance with its formulae or instructions.
WHEREAS , Inphilco, Inc. is willing to supply BAYER PHILIPPINES,INC. with PRODUCTS as specified in ANNEX 2- RELEVANT PRODUCTS.
WHEREAS , BAYER PHILIPPINES,INC. is willing to buy from Inphilco, Inc. the following products :
a. Betafin S1
WHEREAS ,the responsibility of distributing the product is borne by “BAYER PHILIPPINES,INC.” or the company in the name of which the product is being distributed.
1
Quality Agreement between Bayer Philippines, Inc. and
NOW THEREFORE, in consideration of the mutual covenants expressed, the parties agree as follows:
1. Where Regulatory Inspections or BAYER PHILIPPINES,INC. audits identify quality and compliance issues, Finnfeeds Finland Oy should submit a GMP improvement plan, with timings, and shall inform BAYER PHILIPPINES,INC. regularly on the progress in the implementation of this plan.
2. Inphilco, Inc. shall notify BAYER PHILIPPINE,INC. of any regulatory inspections that may directly or indirectly impact on the PRODUCTS supplied to BAYER PHILIPPINES,INC.. Inphilco, Inc. shall inform BAYER PHILIPPINES,INC. of adverse observations from such inspections that may directly or indirectly impact on the PRODUCTS supplied to BAYER PHILIPPINES,INC..
3. Inphilco, Inc. shall, where required, develop internal control limits in coordination with BAYER PHILIPPINES,INC. including limits, which support the expiry period of the PRODUCTS in the Registered Details. Where these internal control limits are set, batches failing the internal control limits shall not be shipped to BAYER PHILIPPINES,INC. until Inphilco, Inc. conducts an appropriate investigation and the outcome acceptable to BAYER PHILIPPINES,INC..
4. Inphilco, Inc. shall supply an agreed Certificate of Analysis as defined in ANNEX 3 . indicating that the batch complies with all agreed specifications and cGMPs.
5. BAYER PHILIPPINES,INC. shall undertake any additional tests, as BAYER PHILIPPINES,INC. deems appropriate.
6.Inphilco, Inc. shall investigate all out of specification (OOS) results in accordance with cGMPs and shall inform the BAYER PHILIPPINES,INC. of the outcome of all investigations.
7..Inphilco, Inc. shall retain batch documentation for 5 years.
8. Inphilco, Inc. shall retain reference samples from each batch of the PRODUCTS and starting materials in accordance with cGMPs. For the batches that are produced at BAYER PHILIPPINES'S facility, BAYER PHILIPPINES,INC. shall retain reference samples from each batch of the resultant products in accordance with cGMPs.
9. Inphilco, Inc. shall investigate all complaints relative to the PRODUCTS supplied to BAYER PHILIPPINES, INC. and shall communicate the data to BAYER PHILIPPINES, INC. within reasonable time.
Definition of Functions and Responsibilities
Article 1
1. The PARTIES follow the Quality Assurance System defined in the current version of the WHO GMP Guidelines.
2
Quality Agreement between Bayer Philippines, Inc. and
2. The contacts and responsible persons are established as set forth in ANNEX 1-CONTACTS AND RESPONSIBLE PERSONS.
3. All functions and responsibilities are in accordance with the rules of Good Manufacturing Practices and Local Requirements (if any; to be defined in ANNEX 3-DEFINITION OF PHARMACEUTICAL RESPONSIBILITIES.) .
4. The PRODUCTS are as specified in ANNEX 2- RELEVANT PRODUCTS..
5. Starting materials and packaging materials shall be purchased only from approved suppliers.
6. Inphilco, Inc. agrees to allow BAYER PHILIPPINES to conduct site inspections.
Article 2
1. This agreement shall become effective with the signatures of both PARTIES. It is concluded for an unlimited period of time and may be cancelled with six (6) month's prior written notice. Both PARTIES may cancel the Agreement with immediate effect if just good cause is existing.
2. Changes and amendments to this Agreement and its Annexes require both PARTIES' mutual consent and shall be made in writing.
3. Should individual provisions in this Agreement be or become legally invalid or should the Agreement contain a gap, then this shall not affect the validity of the remaining provisions. The PARTIES agree to replace an invalid provision of a gap with a provision that is as close as possible to the intended economic effect of the Agreement and which meets legal requirements.
4. All annexes as listed below form part of the Agreement. By the moment, there are:
Annex 1: Contacts and Responsible PersonsAnnex 2: Relevant ProductsAnnex 3 Definition of Pharmaceutical Responsibilities
Bayer Philippines, Inc.
__________________ ____________________ Andrew Mantek General Manager PresidentAnimal Health Division
__________________Ms. Cynthia MiraviteQA & QC Officer
3
Quality Agreement between Bayer Philippines, Inc. and
SIGNED IN THE PRESENCE OF:
_____________________ _________________________
ACKNOWLEDGMENT
Republic of the Philippines )City of ____________ ) S.S.
Before me a Notary Public of _____________, at the above locality, on ___________, 2011, personally appeared: Name Comm. Tax Cert. No. Date/Place of Issue Bayer Philippines Inc. ____________________ _________________Andrew Mantek Passport No.________ Valid up to ____Cercado Danilo _ _________ ________________ _______________ __________________ _________________ ________________ __________________ _________________
known to me and to me known to be the same persons who executed the foregoing QUALITY AGREEMENT , and they acknowledged to me that the same is their own free and voluntary act and deed and the free and voluntary act and deed of the corporations they represent.
IN WITNESS WHEREOF, I have hereunto set my hand and affixed my notarial seal at the place and on the date first above written.
Doc. No. _____Page No. _____ Notary PublicBook No. _____Series of 2011
4
Quality Agreement between Bayer Philippines, Inc. and
Annex 1
Contacts and Responsible Persons
Bayer Philippines, Inc.
Contacts Name Phone/Fax
AH Division General Manager
Andrew Mantek 632 450 3560
632 450 5479Segment Manager
632 450 5479
Technical Operations Manager
Danilo Cercado 632 450 3760
6349 549 2950
QA/QC Officer Cynthia Miravite 632 450 3764
6349 549 2950
Responsible persons
Responsible for storage anddistribution
Arlen Blanco 632 450 3773
632 450 5491
Responsible for QA/QC Cynthia Miravite 632 450 3764
6349 549 2950
Responsible for Regulatory Affairs
Jesshanie Tabaniag 632 450 3770
6349 549 2950
5
Quality Agreement between Bayer Philippines, Inc. and
Contacts and Responsible Persons
Contacts Name Phone/FaxPresident/Executive Vice-President
Gregorio B. AbreuCristina A. Dator
T: 371-1908F: 371-1917
Responsible for Marketing/Distribution
Delfin A. Anareta T: 371-1908F: 371-1916
Responsible for Quality Assurance/Quality Control
William Roger Uy T: 396-1774F: 419-1314
Responsible for Regulatory Affairs /Accounting Officer
Norma E. FlorencioLorenza B. Camus
T: 371-1908F: 371-1916
Annex 2
Relevant Products:
1- Betafin S1
6
Quality Agreement between Bayer Philippines, Inc. and
Annex 3
Definition of Pharmaceutical Responsibilities
Products : (refer to Annex 2)
Inphilco, Inc.
Bayer Philippines
Holder of the marketing authorization - X
Manufacturing and testing in compliance with the marketingauthorization
X
A. Product Materials Primary packaging components X Secondary packaging components X Packaging X Quality Control X Process Validation and Validation of analytical methods X Release for Dispatch X Final Release for Sale or Supply X Stability/Follow-up stability testing of finished product
X
Annual Product Review X
7
Quality Agreement between Bayer Philippines, Inc. and
Inphilco, Inc. will provide the following documentation:
Every Consignment
On Request
Packaging materials for transport/storage of ProductsTest certificate XCertificate of safety for pharmaceutical use X
Raw/Packaging MaterialsPackaging record (only for inspection) XIn-process control records (only for inspection) XCertificate of Analysis/Packaging Certification XConfirmation of correct manufacturing/refilling/testing X
Other documentationSafety data sheets-Finished product (Raw/Packaging Material) XAnnual Material Review (Data) XValidation report of raw and packaging material process X-Validation of analytical methods (raw materials) X-Cleaning validation X-Process validation X
8
Quality Agreement between Bayer Philippines, Inc. and
Quality Agreement
This AGREEMENT, made and entered into this ________________, 2011 at Canlubang Industrial Estate, Calamba, Laguna, Philippines by and between:
BAYER PHILIPPINES, INC. a corporation duly organized and existing by virtue of the laws of the Republic of the Philippines with principal office address located at Bayer House, Canlubang Industrial Estate, Calamba City, Laguna 4028, Philippines and herein represented by its General Manager-Animal Health Division, Mr. Andrew Mantek, and Ms. Cynthia Miravite, QA & QC Officer and hereinafter referred to as “BAYER PHILIPPINES, INC.”;
-and-
Inphilco, Inc ., a corporation duly organized and existing by virtue of the laws of the Philippines_________ with principal office address located at 7 th Floor Ave Maria Bldg. 1517 Quezon Ave. , Quezon City________ and herein represented by its ________ , ________________________ and hereinafter referred to as “______________ ”; together referred to as the PARTIES.
Witnesseth that :
Preliminary Remarks
In the Pharmaceutical industry, contract manufacturing means the production, processing, packaging and quality control of materials or pharmaceuticals with a division of responsibilities. WHEREAS , the purpose of this Agreement is to define and establish the obligations and responsibilities of BAYER PHILIPPINES, INC. and Inphilco, Inc._ relating to the Quality requirements of the PRODUCTS manufactured by Lican Paraguay S.A. and supplied to BAYER PHILIPPINES, INC. in accordance with cGMPs.
WHEREAS , Lican Paraguay S.A. manufactures, processes, packages and tests the products on its own responsibility, in accordance with its formulae or instructions.
WHEREAS , Inphilco, Inc. is willing to supply BAYER PHILIPPINES,INC. with PRODUCTS as specified in ANNEX 2- RELEVANT PRODUCTS.
WHEREAS , BAYER PHILIPPINES,INC. is willing to buy from Inphilco, Inc. the following products :
a. Prolechon
WHEREAS ,the responsibility of distributing the product is borne by “BAYER PHILIPPINES,INC.” or the company in the name of which the product is being distributed.
9
Quality Agreement between Bayer Philippines, Inc. and
NOW THEREFORE, in consideration of the mutual covenants expressed, the parties agree as follows:
1. Where Regulatory Inspections or BAYER PHILIPPINES,INC. audits identify quality and compliance issues, Lican Paraguay S.A. should submit a GMP improvement plan, with timings, and shall inform BAYER PHILIPPINES,INC. regularly on the progress in the implementation of this plan.
2. Inphilco, Inc. shall notify BAYER PHILIPPINE,INC. of any regulatory inspections that may directly or indirectly impact on the PRODUCTS supplied to BAYER PHILIPPINES,INC.. Inphilco, Inc. shall inform BAYER PHILIPPINES,INC. of adverse observations from such inspections that may directly or indirectly impact on the PRODUCTS supplied to BAYER PHILIPPINES,INC..
3. Inphilco, Inc. shall, where required, develop internal control limits in coordination with BAYER PHILIPPINES,INC. including limits, which support the expiry period of the PRODUCTS in the Registered Details. Where these internal control limits are set, batches failing the internal control limits shall not be shipped to BAYER PHILIPPINES,INC. until Inphilco, Inc. conducts an appropriate investigation and the outcome acceptable to BAYER PHILIPPINES,INC..
4. Inphilco, Inc. shall supply an agreed Certificate of Analysis as defined in ANNEX 3 . indicating that the batch complies with all agreed specifications and cGMPs.
5. BAYER PHILIPPINES,INC. shall undertake any additional tests, as BAYER PHILIPPINES,INC. deems appropriate.
6.Inphilco, Inc. shall investigate all out of specification (OOS) results in accordance with cGMPs and shall inform the BAYER PHILIPPINES,INC. of the outcome of all investigations.
7..Inphilco, Inc. shall retain batch documentation for 5 years.
8. Inphilco, Inc. shall retain reference samples from each batch of the PRODUCTS and starting materials in accordance with cGMPs. For the batches that are produced at BAYER PHILIPPINES'S facility, BAYER PHILIPPINES,INC. shall retain reference samples from each batch of the resultant products in accordance with cGMPs.
9. Inphilco, Inc. shall investigate all complaints relative to the PRODUCTS supplied to BAYER PHILIPPINES, INC. and shall communicate the data to BAYER PHILIPPINES, INC. within reasonable time.
Definition of Functions and Responsibilities
Article 1
1. The PARTIES follow the Quality Assurance System defined in the current version of the WHO GMP Guidelines.
10
Quality Agreement between Bayer Philippines, Inc. and
2. The contacts and responsible persons are established as set forth in ANNEX 1-CONTACTS AND RESPONSIBLE PERSONS.
3. All functions and responsibilities are in accordance with the rules of Good Manufacturing Practices and Local Requirements (if any; to be defined in ANNEX 3-DEFINITION OF PHARMACEUTICAL RESPONSIBILITIES.) .
4. The PRODUCTS are as specified in ANNEX 2- RELEVANT PRODUCTS..
5. Starting materials and packaging materials shall be purchased only from approved suppliers.
6. Inphilco, Inc. agrees to allow BAYER PHILIPPINES to conduct site inspections.
Article 2
1. This agreement shall become effective with the signatures of both PARTIES. It is concluded for an unlimited period of time and may be cancelled with six (6) month's prior written notice. Both PARTIES may cancel the Agreement with immediate effect if just good cause is existing.
2. Changes and amendments to this Agreement and its Annexes require both PARTIES' mutual consent and shall be made in writing.
3. Should individual provisions in this Agreement be or become legally invalid or should the Agreement contain a gap, then this shall not affect the validity of the remaining provisions. The PARTIES agree to replace an invalid provision of a gap with a provision that is as close as possible to the intended economic effect of the Agreement and which meets legal requirements.
4. All annexes as listed below form part of the Agreement. By the moment, there are:
Annex 1: Contacts and Responsible PersonsAnnex 2: Relevant ProductsAnnex 3 Definition of Pharmaceutical Responsibilities
Bayer Philippines, Inc.
__________________ ____________________ Andrew Mantek General Manager PresidentAnimal Health Division
__________________Ms. Cynthia MiraviteQA & QC Officer
11
Quality Agreement between Bayer Philippines, Inc. and
SIGNED IN THE PRESENCE OF:
_____________________ _________________________
ACKNOWLEDGMENT
Republic of the Philippines )City of ____________ ) S.S.
Before me a Notary Public of _____________, at the above locality, on ___________, 2011, personally appeared: Name Comm. Tax Cert. No. Date/Place of Issue Bayer Philippines Inc. ____________________ _________________Andrew Mantek Passport No.________ Valid up to ____Cercado Danilo _ _________ ________________ _______________ __________________ _________________ ________________ __________________ _________________
known to me and to me known to be the same persons who executed the foregoing QUALITY AGREEMENT , and they acknowledged to me that the same is their own free and voluntary act and deed and the free and voluntary act and deed of the corporations they represent.
IN WITNESS WHEREOF, I have hereunto set my hand and affixed my notarial seal at the place and on the date first above written.
Doc. No. _____Page No. _____ Notary PublicBook No. _____Series of 2011
12
Quality Agreement between Bayer Philippines, Inc. and
Annex 1
Contacts and Responsible Persons
Bayer Philippines, Inc.
Contacts Name Phone/Fax
AH Division General Manager
Andrew Mantek 632 450 3560
632 450 5479Segment Manager
632 450 5479
Technical Operations Manager
Danilo Cercado 632 450 3760
6349 549 2950
QA/QC Officer Cynthia Miravite 632 450 3764
6349 549 2950
Responsible persons
Responsible for storage anddistribution
Arlen Blanco 632 450 3773
632 450 5491
Responsible for QA/QC Cynthia Miravite 632 450 3764
6349 549 2950
Responsible for Regulatory Affairs
Jesshanie Tabaniag 632 450 3770
6349 549 2950
13
Quality Agreement between Bayer Philippines, Inc. and
Contacts and Responsible Persons
Contacts Name Phone/FaxPresident/Executive Vice-President
Gregorio B. AbreuCristina A. Dator
T: 371-1908F: 371-1917
Responsible for Marketing/Distribution
Delfin A. Anareta T: 371-1908F: 371-1916
Responsible for Quality Assurance/Quality Control
William Roger Uy T: 396-1774F: 419-1314
Responsible for Regulatory Affairs /Accounting Officer
Norma E. FlorencioLorenza B. Camus
T: 371-1908F: 371-1916
Annex 2
Relevant Products:
1- Prolechon
14
Quality Agreement between Bayer Philippines, Inc. and
Annex 3
Definition of Pharmaceutical Responsibilities
Products : (refer to Annex 2)
Inphilco, Inc.
Bayer Philippines
Holder of the marketing authorization - X
Manufacturing and testing in compliance with the marketingauthorization
X
A. Product Materials Primary packaging components X Secondary packaging components X Packaging X Quality Control X Process Validation and Validation of analytical methods X Release for Dispatch X Final Release for Sale or Supply X Stability/Follow-up stability testing of finished product
X
Annual Product Review X
15
Quality Agreement between Bayer Philippines, Inc. and
Inphilco, Inc. will provide the following documentation:
Every Consignment
On Request
Packaging materials for transport/storage of ProductsTest certificate XCertificate of safety for pharmaceutical use X
Raw/Packaging MaterialsPackaging record (only for inspection) XIn-process control records (only for inspection) XCertificate of Analysis/Packaging Certification XConfirmation of correct manufacturing/refilling/testing X
Other documentationSafety data sheets-Finished product (Raw/Packaging Material) XAnnual Material Review (Data) XValidation report of raw and packaging material process X-Validation of analytical methods (raw materials) X-Cleaning validation X-Process validation X
16
