Date: 09/05/2021

Med Corrective Action Plan

Completion
# Deviation Corrective action
date
1 There is one incubator in the Lab. Another Incubator will be added. 30 working days
2 Batch record not found. Batch record will be prepared. 30 working days
Step over bench in the primary
Step over bench in the primary gowning of the
3 gowning of the production area, is -
production area, is exist and fixed.
found but not fixed.
Step over bench in the secondary
There is an Air shower room so the step over
4 gowning of the production area, is -
bench is not required
not found.
Air Shower found but not working
5
during visit.
The Air Shower is working manually. -
Interlock: Air shower doors which
6
was not working
All machines SOPs are hanging on the
7 Machine SOPs are not found. -
machines or behind it.
Quality control: Reference must The Reference shall be mentioned in all Test
8 30 working days
be mentioned in all test methods. methods
There is a colored Tap on the floor instead of
Quality control: Special gown of
9 Step over bench (Acc. To Dr. Mostafa, -
LAF need step over bench.
Inspector of M.O.H, recommendation)
1 There is NO NCR on the Microbial count
Quality Control: No NCR found. -
0 during 2021.
Warehouse: Records of the temp.
1 The record was completed till the day of the
and humidity monitor is not -
1 visit.
completed.
1 Warehouse: Some products
All products will be put on the pallets. Done
2 found directly on the floor.
There is a separated place for ETO Tube but it
1 Sterilization: Place for ETO Tube
was not identified. So, the identification is Done
3 is not found.
hanged
1 Sterilization: No. of BIs used 1- According to ISO 11135, the no. of the BIs -
4 during routine are 3 where it must in the routine work must be 2.5 for each
be 5 according to using of 10 in 1m3 then where our sterilizer area is 1m3 so
the validation. we use 3 BIs.
2- According to ISO 11135 and Notified body
recommendations, there must be two

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# Deviation
Documentation: Packaging
1
Validation from IETQAN in 2018
5
need modification.
Documentation: quantity in the
1 work order of the batch file need
6 to be modified to the actual
quantity produced
Documentation: Batch policy
1 2- In Lot No. identification:
revised but not match with
7 “MM: Serial changed for each size of
example sample.
1 Documentation: Customer
8 Complaints not found
Date: 09/05/2021
Completion
Corrective action
date
methods for BIs used in Validation, EPCD
& IPCD to cover:
a. the routine packaging (Put the BI inside
the normal pack as the product) and;
b. the worst case (Put the BI inside a
syringe)
so, we use 5 BIs for each one of these two
cases but the no. of all these BIs is not
combinate but each one of these methods are
being handled as a separated method.
By the way, this won’t have an effect on the
no. of BIs in the routine work which must be
half of no. of them used during the validation.
There are 2 packaging validation protocol and
report for two families of sutures:
1- One Packaging Validation for SURLENE
Sutures as a non-absorbable suture
2- Another packaging validation for SURCRYL -
Suture as an absorbable suture.
Where all sutures are produced, packed and
sterilized under the same processes and also,
all sutures are packaged in the same pouch.
The quantity mentioned in the work order is the
planned quantity not actual quantity and it will Done
be edited in the work order form to be clear.
1- In Batch No. Identification: The abbreviation
(G) of the Surcryl (PGA) will be added.
Done
product” shall be edited to be start 01 for
each year.
There are no customer complaints recorded. -
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