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GMP+ B2- TS 1.2- Purchase- Gatekeeper Protocol

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Posted 16 February 2022 - 02:15 PM

Can anyone advice under GMP+ B2 standard with reference to Ts1.2 Purchase- if a GMP+ certified company using external facility (non GMP+ certified) for production process means the certified company send the feed materials to non certified facility to process the feed materials and send back the processed feed materials to GMP+ company, does the external facility is considered as service provider? Means which gatekeeper protocols applies when non certified external facility is used if the processed feed materials are to be export to Europe countries later?


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Posted 03 April 2023 - 06:22 AM

Gatekeeper for the raw material must have survey form as they are validated as a supplier.

And the form cannot be answered by the dealer and distributor of the raw material

Below is the content of the GMP+ B2 Gate Keeper Raw Material of BHT.

a)   Contents

b)     Requesting Company information. 2

c)      General information. 2

d)     Requested of Information. 3

e)     Appendices. 4

f)      Premises, Equipment & Facilities. 4

g)      Specification of the Raw Material including its origin and method of Production. 5

h)     Brief / Detail Process Diagram.. 6

i)       Document and Records Control 7

j)       Training. 7

k)      Visitor Policy. 7

l)       Personal Hygiene & Disease Control 8

m)    Premises, Equipment & Facilities. 9

n)     Glass and Wood Policy. 10

o)     Pest Control 10

p)     Identification/Traceability. 10

q)     Sampling. 10

r)      Product Recall 11

s)      Hazard identification + risk assessment per process step. 11

t)      Purchasing. 12

u)     Receiving, Storage, Delivery & Shipping. 12

v)      Sales and Contract. 13

w)    Labelling and delivery requirements. 13

x)      Transport. 13

y)      Complaints. 14

z)      Chemical Control 14

aa)   Processing. 14

bb)   Quality Control 16

cc)    Foreign Matter Control 16

dd)   Control of Nonconforming Product. 17

ee)   Internal Audit. 17

ff)     The written agreement with the supplier (contract). 18

Edited by simonyee.budifeed, 03 April 2023 - 06:27 AM.

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