GLOBAL MEDIKIT LIMITED

FUNCTIONS OF QUALITY DEPARTMENT

Name of
responsible
S.
Section Types of work Detailed specification Frequency person who
No.
perform the
job
Ensure that product quality adheres to a defined set of criteria or meets the requirements of the
A. Quality control
customer. 
1. Verify the sampling advice
2. Verify the physical condition of received materials
3. Collect samples as per plan
4. Maintain the log with full detail of the material
Verify the
5. Check the samples by visually, dimensionally and
1. Incoming stage materials which is Daily
functionally.
procure
6. Prepare the reports as ok or not ok. If not ok, initiate to
take deviation if the material has to be used. If not
used, raise a rejection report against the non conforming
material
2. In-process stage
1. Check the components as visually, dimensionally, and
functionally frequently or as per sampling plan
Verify the
(i) Molding 7. Maintain the log with full detail of the component
components Daily
section 2. Prepare the reports of the component
during molding
3. Raise the rejection report against the non conforming
component
1. Check the product as visually, dimensionally and
functionally
2. Maintain the log with full detail of the product
(ii) Assembly Verify the product
3. Raise rejection report against the non conforming Daily
section during processing
product
4. Take CAPA against the non conformity
5. Take deviation if any
(iii) Blister/ Verify the product 1. Check the packaging information on the wrapper/unit Daily
checking & during pouch according to the approved artwork
packing blister/Checking & 2. Check the product packing for printing, sealing integrity
section packing etc.
3. Verify the product whether it is free from any physical
 defects
4. Verify the product whether it is pack as per
customer/product specification and as specified in the
procedures or batch manufacturing record (MA) copy
5. Raise rejection report against non conformity
6. Take CAPA against non conformity
7. Maintain the log
8. Prepare the reports of the batch
1. Check the product to verify that it is free from any
physical defects (visual, dimensional and functional) and
Verify the product
can be dispatch
Finished Goods physical for its
3. 2. Prepare CPA of the batch Daily
testing performance
3. Maintain the log of the control sample
before dispatch
4. Preserve the control sample of the batch according to
sample size mentioned in the procedure
1. Preparation of test fluid for sterility testing
2. Preparation of the culture media for sterility testing
3. Sterile the accessories and other apparatus by
autoclaving procedure
4. Operate the lab equipments (autoclave, pH meter,
electronic weighing balance, BOD, Oven, LAF, Hot place
etc.) Daily and/or
Verify the product 5. Perform sterility testing frequently as
whether it is free 6. Perform product bio burden specified
from any 7. Perform environment bio burden of different clean room
4. Microbiological testing
microorganism by and controlled area
analysis of the 8. Perform growth promotion test of new received lot of
product sample the culture media
9. Perform biological indicator test
10. Preserve microorganism by culturing or sub culturing
11. Maintain logs for different lab equipment and testing
12. Prepare reports for sterility testing, BET, growth
promotion test, product bio burden, environment bio
burden, biological indicator test
13. Maintaining of sterility and micro labs
5. Chemical testing Analysis the 1. Preparation of reagents for testing Daily and/or
product 2. Preparation of product samples for testing frequently as
performance 3. Perform physico chemical testing of plastic granules, specified
through chemical incoming materials and FG products
testing 4. Maintain log for chemical testing and analytical reagents
 5. Prepare chemical testing analysis reports
6. Prepare lubricants (Silicone fluid) for I.V Cannula process
7. Prepare chemicals for manufacturing process
Determining whether a product meets specified requirements by establishes and maintains set
B. Quality Assurance requirements for developing or manufacturing reliable products and providing confidence that quality
requirements will be fulfilled
Assisting in the
implementation
1. Performs QA document control function, including
and maintenance
document preparation, approval, distributing and
of the Quality
archiving in compliance to internal and external
Management
requirement sand as per ISO 13485:2016.
System (QMS)
2. Coordinates the revision, review, and approval of SOPs,
through revision,
WI and other documents.
(i) QA review, and Daily and/or
3. Reviews quality outputs, change control, validation and
Documentation approval of SOPs as required
qualification documents.
and other
4. Maintain change control and deviation processes for
documents
SOPs, specifications, WI, test methods, validation
ensuring
protocols/reports and other documents.
compliance with
5. Participates in internal audits and supporting external
applicable
audits
regulatory
standards
(ii) Regulatory Regulatory affairs 1. Studying scientific and legal documents Daily and/or
Affairs act as a link 2. Gathering, evaluating and organizing, managing and as required
between collating information in a variety of formats
manufacturers 3. Ensuring compliance with regulations set by the different
and regulatory regulatory authorities (MHRA, ANVISA, USFDA, MOH
authorities, etc.)
ensuring that 4. Maintaining familiarity with company product range
products are 5. Planning, undertaking and overseeing product trials and
manufactured and regulatory inspections
distributed in 6. Keeping up to date with changes in regulatory legislation
compliance with and guidelines
appropriate 7. Analyzing complicated information, including trial data
legislation 8. Offering advice about company policies, practices and
systems
9. Obtaining marketing permission
10. Outlining requirements for labeling, storage and
packaging
11. Liaising and negotiating with regulatory authorities
 12. Providing advice about regulations to manufacturers
13. Writing comprehensible, user friendly, clear product
information leaflets and labels
14. Ensuring that quality standards are met and submissions
meet strict deadlines

1. Technical file/Device master file of products

2. Device design file (Optional)
3. Customer complaints
4. Internal audits
5. CAPA and deviations
6. Calibrations of process and testing equipments
7. Process validation
(iii) Other 8. Product validation Daily and/or
documentation 9. Equipment validation (DQ, IQ, OQ, PQ) as required
10. EO sterilization process validation
11. Packaging validation
12. HVAC validation
13. Analytical method validation
14. Cleaning process validation
15. Disinfectant validation
16. Statistical data analysis
1. Ensuring the documentation of the process needed for
Ensuring the
the Quality Management System (ISO 13485:2016)
documentation of
2. Reports on the performance of the QMS to top
the process Frequently
management
(iv) QA needed for and as &
3. Ensuring the promotion of awareness of applicable
Representative Quality when
regulatory requirements through the organization
Management required
4. review the quality policy
System (ISO
5. Review of the quality objectives
13485:2016)
6. Conduct the management reviews
(v) QA Manager Responsible for 1. Draft quality assurance policies and procedures Daily and/or
planning, 2. Interpret and implement quality assurance standards as required
directing, 3. Evaluate adequacy of quality assurance standards
overseeing and 4. Devise sampling procedures and directions for recording
leading the work and reporting quality data
of a group of 5. Review the implementation and efficiency of quality and
quality personnel inspection systems
6. Plan, conduct and monitor testing and inspection of
materials and products to ensure finished product quality
 7. Investigate customer complaints and non-conformance
issues
8. Document internal audits and other quality assurance
activities
9. Investigate customer complaints and non-conformance
issues
10. Collect and compile statistical quality data
11. Analyze data to identify areas for improvement in the
quality system
12. Develop, recommend and monitor corrective and
preventive actions
13. Prepare reports to communicate outcomes of quality
activities
14. Identify training needs and organize training
interventions to meet quality standards
15. Coordinate and support on-site audits conducted by
external providers
16. Evaluate audit findings and implement appropriate
corrective actions
17. Monitor risk activities
18. Responsible for document management systems
19. Assure ongoing compliance with quality and regulatory
requirements
1. Make certain that production and manufacturing lines
perform efficiently
2. Coordinate employee efforts
3. Facilitate communications between management and
production department
4. Communication with sales and marketing team regarding
Daily and/or
(vi) QC Manager the specifications of product
as required
5. Implementing new processes
6. Communicating quality standards
7. Training staff on new procedures
8. Attending meeting
9. Supervising inspection and other staff
10. Assisting external auditors and inspectors