hey, i was wondering if anyone can help me ot here???


As part of my Masters degree, I doing a project on Good Manufacturing Practice implementation on a manufacturing facility that is the ingredient supplier for a variety of products (personal care, dietary supplement, etc).

My dilemma is that I have no idea how to begin the implementation. :confused: I have
carried out a literature review on the requirements of GMP standards and
have an understanding of how GMP will fit into the Quality System of the company. But I’m not sure where to head to next. How would you even start to compare the differences between the current SOPs and the required?

Any advice on this area would be greatly appreciated. :)

Dazed and very confused
:thanx:

I suggest you do a gap analysis.
Write up an audit checklist based on the GMPs you're using.
Then go through existing procedures and check off what's covered.
What's left are the gaps that you need to fill.

thanks Discordian.

i'm completely new to the area of quality management, as you can probably tell.
i'm in the process of trying to do that. but just having a little trouble actually doing the gap analysis. e.g. in the GMP standards, it is necessary for the building to prevent the contamination. and the company's Quality Manual states similar type of thing.
but my job here is to actually identify what should be done to eliminate contamination. and this is where i'm sort of stuck. :frust:

thanks for your comments!

my job here is to actually identify what should be done to eliminate contamination. and this is where i'm sort of stuck.

Firstly, welcome to the Cove. Pl mention specifically what you want as GMP means a lot; right from the receipt of the raw materials and packing materials in your plant until the finished goods out of the gate and beyond.

Is your job only to list the measures to eliminate contamination ?

thanks for the welcome.

no, my job is to find the relevant GMP standards on the products of the company, and implement the GMP standards on the manufacturing facility, which includes eliminating contamination. from what i understand, my project is based on the whole GMP standards, but probably not including labelling the products, etc.

hope that made some sense.

In that case, I suggest the following -

1. Make a list of all your internal procedures
2. Do a gap analysis against the GMP requirements
3. Additionally, audit the process to identify gaps
4. Revise the procedures
5. Train all applicable employees.

Looks simple, right :cool:

Best Luck

thanks Discordian.

i'm completely new to the area of quality management, as you can probably tell.
i'm in the process of trying to do that. but just having a little trouble actually doing the gap analysis. e.g. in the GMP standards, it is necessary for the building to prevent the contamination. and the company's Quality Manual states similar type of thing.
but my job here is to actually identify what should be done to eliminate contamination. and this is where i'm sort of stuck. :frust:

thanks for your comments!

seems what you're looking for here are two different things, if I'm reading this right...
1) you're trying to do a gap analysis
2) you're trying to come up with specific procedures.

don't do both at the same time... do the gap analysis first. As you do this you might want to create a cross reference sheet comparing GMP elements to existing Quality Manual sections and procedures.

Then start attacking individual processes like contamination prevention, which in itself can be a large topic... we can talk lot-to-lot cross contamination, cleaning and sanitizing validation, pest control, food and drink on the shop floor policy, clothing and dress code, etc.

Welcome to the Cove!:bigwave:
I don't mean to discourage you, but some consultants are paid tens of thousands of dollars to do the task you seem to be set.

First, let me ask, "Is there any question whether this organization has issues with some of its products which may be a result of NOT following Good Manufacturing Practices?" If yes, those glitches should be the focus of a "root cause" investigation and dealt with first.

Second, creating a GMP-focused production process means starting at the beginning:
Work out the steps in each production cycle of each product. Are there any common processes or machines shared by more than one product? How are such processes or machines dealt with to avoid cross-contamination? Is it effective? Similar methods to prevent contamination from other substances not purposely introduced into the process are examined and tested for effectiveness. One of the best sources for cleaning and sterilization techniques meeting GMP is the individual manufacturer of a machine.

Most GMP can be simply stated as "what's best to produce a pure, uncontaminated product? How do you prove you are doing it effectively and consistently?"

thanks for the welcome Wes :)

the answer to your first question:
the company is not required to raise the production level to GMP standards, so there no current issues. but since GMP standards are becoming mandatory in many parts of the world, the company is choosing to comply with GMP.

the second qestion.
because the company is an ingredient producer, and although they produce ingredients for a few types of product, the ingredient is basically the same, but in different forms. but i'm still trying to understand their processes, so you have brought up a few great points that i can ask my supervisor.


thank you so much for your input. :thanx:

thanks everyone for your inputs. :agree1:

i was wondering if anyone can give me some advice on this: :o

because the terms in the GMP standards are quite vague, such as; the personnel shall have sufficient training, and the manufacturer needs to ensure they receive the training, etc.

how do i determine the type and the level of training is sufficient to obtain the GMP certificate? is there like an industry best practice standards that everyone follows?

thanks again
:thanx:

thanks everyone for your inputs. :agree1:

i was wondering if anyone can give me some advice on this: :o

because the terms in the GMP standards are quite vague, such as; the personnel shall have sufficient training, and the manufacturer needs to ensure they receive the training, etc.

how do i determine the type and the level of training is sufficient to obtain the GMP certificate? is there like an industry best practice standards that everyone follows?

thanks again
:thanx:

In my past dealings with the US FDA they will review your documented process.
If the process is deemed effective then the training part just needs to be documented.
How do you show that you ensure effective training? Give a quiz after the training (and of course save the quiz as proof of training). FDA eats that up.
I used to do "General GMP Training" with a 10 question fill in the blank quiz at the end.

Best practice I've seen for GMP compliance has been Procter & Gamble "19 Key Elements". I attended a 5 day training class in that in 2000.
Don't know if they still used this or have developed a new program since.