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GUIDANCE

coisas vaf

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20 views4 pages

GUIDANCE

coisas vaf

Uploaded by

teste
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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GUIDANCE

 Name and Address of the site

 Name and Address of the parent company (if applicable).

 Name and Address of the legal manufacturer (if applicable)

 Contact details

Telephone

Fax

Email

 Details of the contact person (maximum only two persons)

Name and designation

Telephone

Fax

Email

 Site location marked in Google map (GPS)

2. BRIEF INFORMATION OF THE MANUFACTURER

 Brief information of the firm including the details of legal manufacturer, any information
relevant to understand the manufacturing operations of the particular manufacturing site
including contract manufacturing/Manufacturing under loan license etc.

 Detail of other manufacturing sites under this manufacturer

 Annual turn -over of the company for last three years

 List of exporting countries with evidence from two countries

3. MANUFACTURING ACTIVITIES OF PARTICULAR MANUFACTURING SITE

 Medical Device manufacturing activities as licensed by the Competent Authorities or third


party authorized notified body (Design/Manufacturing (finished or bulk product)/Primary
Packaging/Secondary Packaging/ Sterilization/Quality Control, assembling etc.)

GUIDANCE

Quote the (valid) relevant document as issued by the Competent Authority or third party
authorized notified body. State period of validity of licence document. Any conditions and/or
restrictions should be stated.

4. PRODUCTION
 List of medical devices actually manufactured at the site

GUIDANCE

List should be in a tabulated form including the details of legal manufacturer

 List of other products (except medical device) actually manufactured at the site.

 Indicate whether part of manufacturing process (eg: sterilization, refurbishing, secondary


packaging, batch release etc.) or partially manufactured by other manufacturer for you?

GUIDANCE

Information including the details of company should be submitted in tabulated form

 Brief description of general policy for process validation

5. PERSONNEL

 Organizational chart

 Qualification, experience and responsibilities of key personnel

(name, designation)

 Outline of arrangement for training programme

 Number of employees engaged in the quality assurance, production, storage and distribution

 Health requirement for personnel engaged in production


 Personal hygine requirement including clothing

6. PREMISES AND EQUIPMENTS

 The size of the site, description of buildings and their ages.

 Brief description of ventilation systems. More details should be given for critical areas with
potential risks of airborne contamination (schematic drawings of the systems are desirable).
Classification of the rooms used for the manufacture of sterile products should be mentioned.

 Special areas for the handling of highly toxic, hazardous and sanitizing materials

 Brief description of water systems (schematic drawings of the systems are desirable)
including sanitation

 Maintenance (description of planned preventive maintenance programmes and recording


system)

 Cleaning procedures for

a) Manufacturing area

b) Equipment and machines

 Procedure for Qualification , calibration and validation for equipment

7. QUALITY CONTROL AND ASSURANCE

 Number of specialized person in quality control and assurance

 Procedure for handling quality failures


 Have biocompatibility / biological evaluation /clinical trials carried out for your own
product/s?

 Procedure of release of finished product

 Do you carried out real time stability studies for your product/s?

 Arrangement for handling of rejected materials and products

 Procedure for post marketing surveillance

 Details of own laboratories

 Details of third party laboratories used in addition to your own laboratories?

8. QUALITY MANAGEMENT SYSTEM

 Procedure for self-inspection

 Procedure for audits by external organizations

 Procedure for vendor qualification

9. COMPLAINTS AND PRODUCT RECALL

 Complaint handling system

 Recall procedure

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