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what is 21CFR?

Dear Vitthal,
21 CFR is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).

It is divided into three chapters:

Chapter I — Food and Drug Administration
Chapter II — Drug Enforcement Administration
Chapter III — Office of National Drug Control Policy

check the link please.

Shahid Ali
QA Manager
APF SC, Ethiopia

what is the specificity of the HOLD TIME STUDY

Dear Vitthal
Can u please explain your question, What study u r talking about???

Dear Shahid
hold time study is of two types.
one is dirty equipment hold time
other is cleaned equipment.

in cleaned equipment study u have to prove that particular equipemnt can be hold after cleaning (no.of hours to specify) so that microbial proliferation from cleaned equipment is minimal.
for that at least for 4 days (0,1,2,3,4) dya micro sampling to be done and results r compailed.

validation anayst.

Dear Parasad
U r sharp enough to understand such an ambigous Question on the forum of 21 CFR, anyway i want to add up somthing here actually clean equipment Hold time is the time elapsed from the end of the cleaning process until the beginning of the use of the cleaned equipment for manufacture of the next product and the dirty equipment hold time is the time start from the end of manufacturing to the begining of the cleaning process. Now a days auditor may ask u abt the status of cleaning (Ready to use) and its holding time and does the cleaning SOP describes how long the cleaned equipment can be stored prior to re-cleaning?. History of cleaning log books is also checked to assure the proper hold time before and after cleaning. so all in all it should be established during Cleaning validation and not to be overlooked

Dear Prasad thanks for the reply.

Mr Ali could you please tell me in what way the cleaning validation will be done in a non sterile plant and why it is so required?

Dear Vitthal
Cleaning Validation for non-sterile area and equipment is as important and essential as for sterile one, and u can read a lot of information about cleaning validation in forum

Thanks for the raply Mr.ali.
Please tell me only
Prednisone and Salycilc acid are used for the validation of Dissolution instrument WHY?

Dear Vithaal,
DRUG DISSOLUTION STUDIES are commonly conducted using basket (Apparatus 1)and paddle (Apparatus 2) methods as described in the official compendia (eg, USP,Eur. Ph.). The USP requires that, before using the dissolution apparatuses for drug product analysis, they are to be calibrated with the USPcalibrators according to the Apparatus Suitability Test described in the pharmacopeial general dissolution testingmonograph. The calibrators used for the evaluation are oftwo types, that is, disintegrating (Prednisonetablets) and nondisintegrating (Salicylic Acid tablets). The instruments are considered suitable for dissolution experiments with drug products if the percent of drug released at 30 minutes from the calibrators using water (Prednisone tablets) or phosphate buffer pH 7.40 (Salicylic Acid tablets) falls within a preestablished range. These ranges for each combination of apparatus at 50 or 100 rpm and calibrators are established by the USP based on the data obtained from collaborative studies . The established ranges are usually different for each lot of calibrators.


Thanks for the reply Mr Ali
could you please tell me the role of the PLACEBO in manufacturing of a drug
and why it is so required?

Dear Vitthal,
In qualification studies, the placebo batches is used, due to low cost n due aviod of loss of expensive API in PQ. In PQ, usually when we challenging the equipment for instance cone blender qualification ,you may take placebo batch, and pour dye into it and determine the tentative time of mixing at spercified capacity and RPM. this is the one example of placebo batch use in pharma, in cleaning validation, placebo batch is also use, there are many other items where plaeco batch is utilize.

dear MR. Ali

as you told that placebo batches are used in pq of batches sir can you pl tell me how they can be used in other equipments like in sifter, rmg and fbd and how can we use these results in our specific batches like youu have given the example that in cone blender we can use placebo for mixing time validation with low grade dye to avoid cost of API for eg if we want to validate the mixing time of diclofenac in para+diclo tablet then how this placebo result help us in this batch pl clear my ponits.