Training Session on

GMP & Control of DEG

13 Nov 2022, Hotel Marriott, Karachi

Hi everyone,
I welcome you all in today’s training session organized by CCK/CQS as per the petition of the
program after the sad incidence of dozens of recent reported unfortunate deaths (Young
Children) in Indonesia and Gambia and historically dozens of episodes of tragic deaths are
strongly linked with consumption of contaminated syrups.
The Punch line of Petition of the Program which need attention; “It is nothing but Di Ethylene
Glycol (DEG) present in Glycerin or Propylene Glycol widely used in pharmaceuticals,
nutraceuticals, creams and toothpaste. This contaminant produces 2-Hydroxide ethoxy acetic
acid and thus cause irreversible damage to kidney.”
In my opinion after working in pharmaceutical operations for several decades and still working,
this is very important for our concerted efforts to ensure all our Pharmaceutical/Nutraceutical
products shall be consistently manufacture meeting all quality parameters throughout its shelf
life:
1. Considering Glycerin which is an excipient and our control on the selection and approval
of the qualified sources for an Excipients is also very important. (Don’t consider the
qualification/approval of only those materials which are label claim items, but other
excipients are also very important)

2. In house testing, control both as an excipient in dosage form or as an incoming Raw

material.

3. Also use in Nutraceuticals products which is currently introduce in our market as a

locally manufactured with little or no knowledge of development and manufacturing of
so-called Nutraceutical products.

4. In my opinion this is important to note that we should always consider all Nutraceutical
as an equally important product which need full scientific and technical knowledge
before their commercialization. launch about the manufacturing and development of
each so-called Nutraceutical products.
Please note that working in Pharmaceutical Companies, we proudly claim: That we are the
“Manufacturers & Suppliers of Life Saving Drugs”.
This is only possible if we have:
 People of Quality
 Practices of Quality
 Principles of Quality
  Procedures of Quality
 Policies of Quality
 Premises of Quality
Now my suggestion to all participants who are going to attend the Training Session, “GMP &
DEG Alarm”, the takeaway points are:
 We should always be ready to learn from others mistake and would like to bring
attention of all participants to the opening sentence from Dr. Obaid Ali and Roohi Obaid

 Petition of the Program: “In spite of development in technology, introduction of

regulations and maturing the quality, we failed to resolve a known, preventable issue of
drug manufacturing from 1937 to September 2022. Dozens of recent reported deaths in
Indonesia and Gambia and historically dozens of episodes of tragic deaths are strongly
linked with consumption of contaminated syrups.”

 Going forward we should always consider selections of excipients are equally important.

 Usual thinking prevailing among our technical colleagues working in technical

colleagues (Quality, Manufacturing, Product Development, Supply Chain) that
excipients are not a label claim items therefore their selection of sources/approval/grade
and quality is not important.

 As suggested, we should learn from others mistake, and we are committed to pay equal
attention on the selection of both API and excipients, as both are equally important and
any violation/compromise on Quality principles can cause serious quality issue which
may even lead to death of our Dear and Near ones.

 Wish you all the best and looking forward to talking to you during the Training
Session on November 13th,2022 Inshallah.

Best Regards
Iftikhar Jafri
Maryland, USA