Warnings are because shortcuts. e.g. adequate lighting should mean that workers in any given area are able to clearly see whatever they need to see.To be able to clearly read small print should be ok but documented. Regarding space ,normal working area without touching the neighbor usually 5 CFT/person should be sufficient.
If I may be permitted to add. The comment on Korean company , it seems clear use of shortcut. Training of personals MUST include basics of cGMP with special emphasis on particular work. Lack of practical training (with record) without provision of retraining will invite these kind of comments. It is always better to do little extra than what is required.
Can you please tell me why you need this specific information with respect to batch manufacturing record. I always request that, do not just go on wordings specified in the guideline. The interpretation is very very important. § 211.186 Master production and control records - "Complete manufacturing and 'control instructions', sampling and testing procedures, specifications, 'special notations', and precautions to be followed". Further, § 211.188 Batch production and control records-(13) Results of examinations made in accordance with § 211.134. Also refer § 211.137. Once you refer all these specified informations, all are interlinked like- Master records should have controlled instructions, you can put special notations , examination results should be recorded in line with specified clause(§ 211.134 - This is for Drug product inspection. Further expiration dating (§ 211.137). The point is, when you inspect and review and record in batch record, there should be control instructions to ensure that the compliance with respect to all inspections. Hope, you are clear with it.
Sir, kindly tell me hom many sections except 21 cfr part11 and 21cfr art 210,211 in fda guideline like fda guidance for industry 2011, oos guideline october 2006 .....
What exactly you need to understand? Do you mean to say wrong SOPs? For production related - § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. Similar requirement for warehouse, QC etc under different subhead. I really don't understand about unfilled incomplete SOPs? Becasue SOPs are not filled. They are followed. Please confirm
Please refer § 211.100 Written procedures - These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. Similar requirement is there for QC and other areas. Hope, this will solve your querry.
Sure. Can you please check your subordinates or friends. If there are 10-15 persons, I really like to have FREE session. If many peoples are interested , definitely I will arrange. Please confirm.
@@sohailahmad507 Thanks for your kind reply. Please share me list of persons interested, contact details and organisation. Because, I can prepare example on the basis of their experiance and organisation. Thanks again
I suggest, you use this videos for training to operators also. Initially, let it be in english, followed by you explain them in hindi so that, they will also get confidence about english videos only. Finally, operators need to understand SOP, BMR in english only. !!!
Sure. I am planning to take separate session on this aspect. It needs detailed discussion. So, I will not able to explain in the comment. Meanwhile be in touch and Keep Learning !!!
Dear all; request you to post your questions about this topic. I will be happy to solve your queries.
Warnings are because shortcuts. e.g. adequate lighting should mean that workers in any given area are able to clearly see whatever they need to see.To be able to clearly read small print should be ok but documented.
Regarding space ,normal working area without touching the neighbor usually 5 CFT/person should be sufficient.
Good...
If I may be permitted to add. The comment on Korean company , it seems clear use of shortcut.
Training of personals MUST include basics of cGMP with special emphasis on particular work.
Lack of practical training (with record) without provision of retraining will invite these kind of comments. It is always better to do little extra than what is required.
Right..
Which guidelines & section for equipment qualification in pharmulation & API
This guidelines where found for reading
You can refer subpart D of 21 CFR part 211. Further you can refer other guidelines for qualification - EUGMP,PIC/S,TGA,TPD,WHO and many more....
Iam impressive with ur training sircan you please provide brief training on 211 sub parts in further.that will be helpful for misinterpretations
Thanks
Audit trail check for CDS and NON CDS INSTRUMENT
I will take session on it
Thank You SIr...
Welcome
in which subpart mentioned that manufacturing & expiry date shall be mentioned in batch manufacturing record?
Can you please tell me why you need this specific information with respect to batch manufacturing record. I always request that, do not just go on wordings specified in the guideline. The interpretation is very very important. § 211.186 Master production and control records - "Complete manufacturing and 'control instructions', sampling and testing procedures, specifications, 'special notations', and precautions to be followed". Further, § 211.188 Batch production and control records-(13) Results of examinations made in accordance with § 211.134. Also refer § 211.137.
Once you refer all these specified informations, all are interlinked like- Master records should have controlled instructions, you can put special notations , examination results should be recorded in line with specified clause(§ 211.134 - This is for Drug product inspection. Further expiration dating (§ 211.137). The point is, when you inspect and review and record in batch record, there should be control instructions to ensure that the compliance with respect to all inspections. Hope, you are clear with it.
Sir, kindly tell me hom many sections except 21 cfr part11 and 21cfr art 210,211 in fda guideline like fda guidance for industry 2011, oos guideline october 2006 .....
I understood your question. I will prepare separate session on it. Which will include all different guides and how to access them.
Thank you sir....
Most welcome
Wrong or unfilled incomplete SOPs come under which CFR 210 or 211 subparts??
What exactly you need to understand? Do you mean to say wrong SOPs? For production related - § 211.100 Written procedures; deviations.
(a) There shall be written procedures
for production and process control designed
to assure that the drug products
have the identity, strength, quality,
and purity they purport or are represented
to possess. Such procedures
shall include all requirements in this
subpart. Similar requirement for warehouse, QC etc under different subhead.
I really don't understand about unfilled incomplete SOPs? Becasue SOPs are not filled. They are followed. Please confirm
Thanks for your message sir.. I mean old or unupdated SOPs or there is no recognisable system to manage and update SOPs
Please refer § 211.100 Written procedures - These written procedures, including
any changes, shall be drafted,
reviewed, and approved by the appropriate
organizational units and reviewed
and approved by the quality
control unit. Similar requirement is there for QC and other areas. Hope, this will solve your querry.
These are basic requirements. Applicable for cGMP
Can you please provide training on Analytical method validations
Sure. Can you please check your subordinates or friends. If there are 10-15 persons, I really like to have FREE session. If many peoples are interested , definitely I will arrange. Please confirm.
Yes! Intrested
@@sohailahmad507 Thanks for your kind reply. Please share me list of persons interested, contact details and organisation. Because, I can prepare example on the basis of their experiance and organisation. Thanks again
@@hitendrakumarshah3718 Sure sir! Thanks for kind reply
sohail ahmad great 👍
Pls prepare 2nd part
Sure
Pls provide knowledge on ICH
ICH Guidines
Guidelines
Sure
Sure
I feel such a great informative videos should be in Hindi also so that these informations can be shared with Operatives also...Thank you Sir
I suggest, you use this videos for training to operators also. Initially, let it be in english, followed by you explain them in hindi so that, they will also get confidence about english videos only. Finally, operators need to understand SOP, BMR in english only. !!!
Sound is not clear
OK
ICH GUIDELINE FOR THE DETAILS
Thank you for suggesting the topic. I will conduct training on it.
Can you please explain about stratified sampling and acceptance criteria as per ASTM and ISPE
Sure. I am planning to take separate session on this aspect. It needs detailed discussion. So, I will not able to explain in the comment. Meanwhile be in touch and Keep Learning !!!
Capa effective ness
Yes