Services


CONSULTANCY ON THE GMP AND GDP REQUIREMENTS

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CONSULTANCY ON THE GMP AND GDP REQUIREMENTS

1.1. Independent auditing of quality systems for their compliance with the GMP and GDP requirements.

1.2. Preparation of an enterprise or a site for its certification / licensing under the GMP and GDP requirements.

1.3. Design and implementation of quality systems:

1.3.1. Composition / assessment of the quality system documents:

- quality manual (QM),

- site master file (SMF),

- standard operation procedures (SOP),

- validation master plan (VMP),

- annual quality survey, etc.

1.3.2. Information back-up of an enterprise until obtainment of a certificate / license

1.4. Development and implementation of a risk management system

1.5. Consultancy and an information support of a company at the stage design, refurbishment or reconstruction of pharmaceutical plants

1.6. Any other assistance provided to pharmaceutical enterprises in the context of implementation and maintenance of the GMP and GDP requirements.

VALIDATION AND QUALIFICATION

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VALIDATION AND QUALIFICATION

2.1. Validation

2.1.1. Tracking of all validation works

2.1.2. Process validation (PV) and cleaning validation (CV):

2.1.2.1. Protocol development

2.1.2.2. Holding / maintenance of the validation studies

2.1.2.3. Execution of consolidated reports

2.1.3. Cold chain validation

2.2. Qualification

2.2.1. Tracking of all qualification works

2.2.2. Assistance in drafting Unit Requirement Specification (URS), factory acceptance tests (FAT) and site acceptance tests (SAT) of equipment

2.2.3. Execution of all qualification stages (DQ, IQ, OQ, PQ) of clean premises, storage rooms (temperature mapping), engineering systems, manufacturing and laboratory equipment, transport vehicles:

2.2.3.1. Protocol development

2.2.3.2. Holding / maintenance of qualification tests

2.2.3.3. Execution of consolidated reports

TRAINING

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TRAINING

3.1. Staff training as per GMP and GDP requirements.

3.2. Staff training in the context of a quality system development and implementation (under a quality system).

UPDATE OF DOCUMENTATION RECORDS...

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UPDATE OF DOCUMENTATION RECORDS...

4.1. Composition and updating of a Drug Master File (DMF) for active pharmaceutical ingredients (API)

4.2. Composition and updating of a site master file (SMF)

4.3. Composition and updating of other records needed for the successful functioning of an enterprise on the pharmaceutical market

Contacts

OFFICE IN UKRAINE

Address: 3 Sholudenko Str., office 210, Office Center “Kubik”, Kiev, 04116, Ukraine 

E-mail: office@bsc-gmp.com
Tel.:   +38 (044) 232 38 32
Cell:   +38 (095) 872 34 23
         +38 (098) 991 90 06
Fax:   +38 (067) 441 54 88

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