Cleaning validation

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
#1

Dear All ,

Can a facility that produced penicillin dosage forms be decontaminated and renovated for production of non-penicillin solid dosage forms provided there is no further penicillin production in the renovated facility and what docoumnation/ cleaning validation reqiured can anyboudy explain in brief ?

Regrds

Himanshu C

#2

Dear Mr. Himanshu,

Yes, it is possible to decontaminate a penicillin manufacturing facility and to use the decontaminated facility for non-penicillin products. But the task is not as simple as it may sound. Overall approach can be divided into two phases (a) Decontamination/removal/cleaning of penicillin residues, (b) Residue Monitoring/Sampling. It is the second phase that uses the most of the time.

Like any other cleaning validation studies you would require atleast following documents before a facility could be considered penicillin residue free:

[LIST=1]

  • Risk assessment/analysis (e.g. assess the levels of contamination within the facility, risk of non-penicillin products contaminated with penicillin products).
  • Decontamination efficacy (perform laboratory studies to validate/verify the method used for decontamination of penicillin residues).
  • Cleaning validation (should include recovery studies, analytical method validation etc.)
  • Monitoring (the premises for penicillin residues on a timely basis): for this you may need to take samples from different locations of the facility.

    That was just the brief of a lengthy story. For more information I would suggest you these references:

    [LIST=1]

  • Hakimipour, Fred, “Penicillin Decontamination Procedures for Pharmaceutical Manufacturing Facility,” Pharmaceutical Technology, June 1984.
  • Hisao Takahashi, PE, Hiroshi Sakai, and Dr. Daniel H. Gold; “Case Study: Beta-Lactam Decontamination and Cleaning Validation of a Pharmaceutical Manufacturing Facility,” Pharmaceutical Engineering, November/December 2008, Vol. 28 No. 6.
  • Naoto Fukutsu, Takao Kawasaki, Koichi Saito, and Hiroyuki Nakazawa, “An Approach for Decontamination of b -Lactam Antibiotic Residues or Contaminants in the Pharmaceutical Manufacturing Environment,” Chem. Pharm. Bull. 54(9) 1340—1343 (2006). Thanks & rgds.
    • #3

    I do agree with OVAIS…

    #4

    Thnks Ovasis
    can you provide me above mentioned references.

    regds
    Himanshu c

    #5

    Dear Sir,

    Hai, kindly suggest me

    1. whether any cleaning validation required for scoop used for sampling and dispensing of Key raw material.

    we are cleaning all scoop after every use and checking physically.

    2)Does any dedicated scoop reqired for sampling and dispensing of Key raw material.

    Thanks
    Amrit

    #6

    Dear Amrit,

    Yes, you have to perform cleaning validation for scoops (or spoons or other similar utensils). You may include the scoops (only those having contact with the worst case residue such as active ingredient or cleaning agent and could contaminate the subsequently manufactured products) in the cleaning validation program. Scoops can be sampled along with the equipments (and parts) considered for CV or separately (remember to add the surface area for scoops to the total product contact surface area and calculate the acceptance limits accordingly).
    Dedicated scoops/spoons can be used for raw material sampling and dispensing after considering the toxicity of the material.

    Regards.

    Ovais.

    #7

    [quote=ovais]Dear Amrit,

    Yes, you have to perform cleaning validation for scoops (or spoons or other similar utensils). You may include the scoops (only those having contact with the worst case residue such as active ingredient or cleaning agent and could contaminate the subsequently manufactured products) in the cleaning validation program. Scoops can be sampled along with the equipments (and parts) considered for CV or separately (remember to add the surface area for scoops to the total product contact surface area and calculate the acceptance limits accordingly).
    Dedicated scoops/spoons can be used for raw material sampling and dispensing after considering the toxicity of the material.

    Regards.

    Ovais.[/quote]
    Dear Mr.Ovais,

    Thanks for your reply.
    can you provide me above mentioned references?

    Regard’s
    Amrit

    #8

    Dear Mr.Ovais,

    Can you pl. provide some reference for scoop cleaning validation.

    We are cleaning sampling and dispensing scoop manually and checking visually for cleanness. is it required any cleaning validation?

    thanks & regards
    Amrit Behera

    [quote=akb_amrit]Dear Mr.Ovais,

    Thanks for your reply.
    can you provide me above mentioned references?

    Regard’s
    Amrit[/quote]

    #9

    http://www.ispe.org/galleries/nd08/08nd_takahashi.pdf

    I found this in a article

    Can a facility that produced penicillin dosage forms be decontaminated and renovated for production of non-penicillin solid dosage forms provided there is no further penicillin production in the renovated facility?

    Reference: 21 CFR 211.42(d), Design and construction features; 211.46(d), Ventilation, air filtration, air heating and cooling; 211.176, Penicillin contamination; FDA By-Lines #3, Nov.77, Procedures for the Detection of Residual Penicillins in Drugs; 21 CFR 436.104 Penicillin Activity; and FDA Guide to Inspections of Validation of Cleaning Processes, July 1993.

    Yes. However, the decontamination process is extremely difficult and we are unaware of any firm that has successfully decontaminated a penicillin facility and converted it to production of non-penicillin products.

    Note that at section 211.176 the CGMP regulations require that if a reasonable possibility exists that a non-penicillin drug product has been exposed to cross-contamination with penicillin, the non-penicillin product must be tested for the presence of penicillin and not marketed if detectable levels are found using the codified method. Such a reasonable possibility may be present where decontamination has not been conducted effectively. That would put the responsible firm in a position of having to test each and every lot of non-penicillin product for the presence of penicillin.

    In sum, while the CGMP regulations would not prohibit decontamination and conversion, the difficulty of cleaning up penicillin residues makes the chore daunting.

    Contact for further info: Edwin Melendez, HFD-322, 301-594-0095; e-mail; melendeze@cder.fda.gov