Validation - Part I

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Dear Bloggers, Hello everybody....Please find my first blog for this month, in whcih I am going to provide a brief insight about Validation and its importance. And further in my subbsequent second blog I will highlight about types of validation, phases of validation and developing strategy for validation. The term Validation means an act of establishing and documenting that all the processes, systems, facilities, steps and equipments employed in the production of Pharmaceutical product are well controlled and maintained. All these factors ultimately influence the quality of the product, henceforth must be adequately monitored. The validation is very critical not only to establish that you are able to get a quality product, but at the same time to ensure that, by doing adequate and proper validation , you are able to produce consistent and uniform batches meeting the predetermined specifications. For e.g Validation of granulation process involves, broadly involves Equipment Validation, process validation and Final Product Granule validation (1) Now each and every validation required for the granulation process is further refined and systematic approach is developed by defining the parameters and predetermining the specification . For e.g. Parameters required to be validated in final granules validation are Granule flow, Bulk density, Moisture content, Particle size distribution (Sieve analysis and Granule crushing strength (2) Now the question arises, Do we need to validate all the processes, facilities and equipments .....?? Yes!! Validation is needed in all these system, facilites and equipments where by in each and every step, process should describe the output desired and for this output achievement , a predetermined specifications needs to be developed. Examples : Sterilization processes, Clean room conditions , Lyophilization process. etc Validation is something like without which Pharmaceutical Industry cannot breathe. It determines the quality of the product developed. Henceforth is should be critically studied, evaluated and analysed. Happy Blogging References 1) Nash R A., Wachter A.H., Pharmaceutical process validation, 3 rd edition,Marcel Dekker publication, p.g. no-xxx-xxxiv, 173-182. 2) N. K. Jain & S. N. Sharma, A Text Book of Professional Pharmacy, Vallabh Prakashan, p.g.no. -295-297 Note :"This Blog Does Not Contain Any Plagiarized Material"
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Shikha Chauhan's picture
Author: Shikha Chauhan

Comments

A.R.Khan's picture

The term Validation means an act of establishing and documenting that all the processes, systems, facilities, steps and equipments employed in the production of Pharmaceutical product are well controlled and maintained. The above statement sounded like QA department function. In reality what is the difference between these 2 departments in pharmaceutical industry . Please advise.
Shikha Chauhan's picture

Dear Sir, Very Good Question!! The Validation department is a subset of Quality Assurance department, Validation department works to ensure that the systems works the way that it claims.I means it ensures, that it meets up it pre determined specifications. But it does not comply to the other part of the requirements such as Security systems installed in the company, Audit trails and administrative controls. whereas Quality Assurance cover all these aspects also.

Thanks and Regards, Shikha Chauhan http://www.pharmainfo.net/shikhachauhan/biography Lecturer (Pharmaceutics) Amity Institute of Pharmacy Amity University Noida Email: schauhan@amity.edu

Radha Krishna's picture

hi, quality assurance is governed by quality guidelines of the industry and it is purely technical department under whose perview the quality of the product lies. it has no role in the adminstrative functions of the industry. validations accordingly is always a subset of quality assurance team. analytical method validatons always are function of AD. ramakrishna

Ramakrishna

Indigene Pharmaceuticals

K Rajakrishna's picture

Respected mam, you have explained it well. Can you please explain where does the difference lies in documentation part in quality assurence and validation.
Shikha Chauhan's picture

Dear Raja, I would say again that Documentation need to be controlled in both the departments. Validation team is governed by Quality Assurance Team. Quality Assurance Deals with all the system of the whole company including Administrative control, Audit trails , security etc... for which the documentation is to be done by QA team and not by the validation Team.

Thanks and Regards, Shikha Chauhan http://www.pharmainfo.net/shikhachauhan/biography Lecturer (Pharmaceutics) Amity Institute of Pharmacy Amity University Noida Email: schauhan@amity.edu

Gangadhar Hari's picture

An informative blog discussing about administrative works in an industry. Thank you madam for coming up with such a good blog. Hope we learn more from your blogs.
Shikha Chauhan's picture

All the Best!

Thanks and Regards, Shikha Chauhan http://www.pharmainfo.net/shikhachauhan/biography Lecturer (Pharmaceutics) Amity Institute of Pharmacy Amity University Noida Email: schauhan@amity.edu

SS Md Shafi's picture

Dear mam..

nice blog

plz..give example or procedure for validation of an equipment

shafi ..

Shikha Chauhan's picture

Daer Safi, As I have already stated in my first blog Validation part-I, I shall be covering Equipment Validation in my second blog, Validation Part -II, very sooon.

Thanks and Regards, Shikha Chauhan http://www.pharmainfo.net/shikhachauhan/biography Lecturer (Pharmaceutics) Amity Institute of Pharmacy Amity University Noida Email: schauhan@amity.edu

Shouvik's picture

MADAM I HAVE NOT UNDERSTOOD THE THERMAL DEATH TIME i.e. D VALUE, F VALUE, Z VALUE ETC. FROM LACHMAN. CAN YOU PLEASE SIMPLIFY IT.

$houvik

Shikha Chauhan's picture

Thermal Death Time: This is the time in minutes, necessary to kill a given number of organisms at a specified temperature. D-Value: This indicates time in minutes at a constant temperature, that is necessary to destroy 90% or 1 log of the organism present at a given reference temperature. A D-value at one temperature, along with a z-value, is used to define the heat resistance of a microorganism. z-Value: This is the temperature increase required to reduce the thermal death time by a factor of 10. It is the number of degrees between a 10-fold change (or log cycle) in a microorganism's heat resistance. The z-value is considered a constant for a given microorganism strain in a given product. F-Value: This is the process lethality or the time in minutes, at a specific temperature required to destroy a certain number of viable cells. I hope you are clear now!

Thanks and Regards, Shikha Chauhan http://www.pharmainfo.net/shikhachauhan/biography Lecturer (Pharmaceutics) Amity Institute of Pharmacy Amity University Noida Email: schauhan@amity.edu

Sudha Thamarapalli's picture

Hello mam, Nice blog from you. Does validation(especially in equipments) performed manually or else are there any other alternatives.

Regards,

Sudha.T

Shikha Chauhan's picture

Thanks!! Validation is performed (in the case of euipments) manually as well as various through various computer system validation. Prior to testing by Equipments ...they must qualify following stages: a) Design Qualification (DQ) b) Installation Qualification (IQ) c) Operational Qualification (OQ) d) Performance Qualification (PQ) e) Component Qualification (CQ) The details of which I will discuss in my second blog Validation Part -II.

Thanks and Regards, Shikha Chauhan http://www.pharmainfo.net/shikhachauhan/biography Lecturer (Pharmaceutics) Amity Institute of Pharmacy Amity University Noida Email: schauhan@amity.edu

Radha Krishna's picture

hi, validation of equipment is carried out manually along with the help of certian man-machine interfaces like tachometer etc. also if a eqipment has PLC (programable logic controlers)validation of these are done using softwares and computers. ramakrishna

Ramakrishna

Indigene Pharmaceuticals

Alok Gupta's picture

Hello Mam, my querry is regarding 'process validation' for tablet production.... in detail.its a kind request please suggest me some site links or books for this? Regards alok gupta
Navya Sai's picture

Hi mam, nice blog.can u please tell me about granule strength in validation of final granules.

Regards,

Navya sai

Shikha Chauhan's picture

Granule strength is analysed in terms of compressive, tensile, shear, bending, impact and abrasion test. For every granule there is an optimum range of average granule crushing strength. Compressive strength of granule has been investigated by placing individual granule between two plates and breaking them by application of a compressive load .

Thanks and Regards, Shikha Chauhan http://www.pharmainfo.net/shikhachauhan/biography Lecturer (Pharmaceutics) Amity Institute of Pharmacy Amity University Noida Email: schauhan@amity.edu

Megha Madhubhai's picture

hello mam, it's nice. can you give me information about "validation parameter"

megha

Radha Krishna's picture

hi, as for your question on validation parameters, only analytical method validation has predefined parameters. and these parameters are officially given by ICH and harmonized and interchangable in all the three regions. as for the process validation there is no predefined set of parameters. one has to validate all the crictical process vaariables that can effect the quality of the product.please do write to me in case you have further doubts regaarding any validations. ramakrishna manager-regulatory affairs

Ramakrishna

Indigene Pharmaceuticals

Shouvik's picture

MADAM PLEASE TELL HOW VALIDATION OF BIOASSAYS CAN BE DONE.........................I HAVE NOT SEEN THIS TOPIC IN ANY OF THE PHARMACY BOOKS TILL NOW..........AND I THINK WHATEVER WE DO IN PHARMACOLOGY PRACTICALS THAT IS A WASTE BECAUSE NO VALIDATION OF EXPERIMENTS CAN BE DONE................

$houvik

Radha Krishna's picture

hi, validation of bioassay is a different topic and the experiments you do in pharmacology is different. and the your college practicals are very important for graduates. as per the bioassays i can give u details in another blog of mine

Ramakrishna

Indigene Pharmaceuticals

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