What is the Role of Quality Unit? What ICH guideline says?

Easy Learning ICH Q7-Part 3 by Anshu Yadav

Quality Unit-Role and Function

An independent Quality unit is an essential requirement of the ICH guidelines. Thus it is required to know the function of a Quality unit [Section 2.2 of ICH].

     

Handle	All quality related matters.
Review	Validation protocols & report, Quality related document, Batch             Production and laboratory control records before release of API.
Release	APIs, Intermediates, Raw material, Packaging material and labeling                 material.
Reject	APIs, Intermediates, Raw material, Packaging material and labeling             material.
Approve	Specification, Master production Instruction, All procedures          impacting quality of Intermediate/API, Validation protocols &          reports and approving intermediate and contract manufacturers.
Perform	Product Quality Review
Ensure	Critical deviation and quality related complaints are investigated &             resolved, Internal audit are performed
	Effective systems are used for maintaining and calibrating critical            equipment.
	Materials are appropriately tested and results are reported.
	Stability data is there to support retest or expiry dates and storage            condition

The Quality control is responsible for the laboratory control function [Section 11 of ICH].To conduct all the above activity, the quality unit should have an adequate laboratory facilities.

Laboratory control [Section 11 of ICH]  

General Control

·        Documented procedure for all the relevant activities of the Quality Unit [Section 6.6]

·        Scientifically sound test procedure, specification and sampling plans.

·        Specifications which should include

o Appropriate specification in accordance with accepted standard and consistent with the manufacturing process

o Control of Impurity

o Microbiological purity (if applicable) –[Action limit for total microbial counts and objectionable organism should be established]

o Endotoxin(if applicable)

·        The activity should be recorded at the time of performance.

·        All the function mentioned in Section 2.2 of ICH should be followed.

Testing of Intermediate and APIs

Laboratory test are conducted to determine the requirement of specifications are fulfilled or not. The manufacturer should provide adequate laboratory facility to the quality unit. Appropriate microbiological test should be conducted on each batch of intermediate & API where microbial test is required. Impurity profile should be maintained

At regular interval the impurity profile should be challenged against regulatory submission or against historical data. This is required to detect if modification in RM/PM, equipment, operating procedure or the production process.

Exception: Not necessary for herbal/animal tissue origin.

Certificate of analysis:

Quality control should issue certificate of Analysis for an API or Intermediate at the time of releasing the batch. This COA should be shared with customer on request. 

Elements of COA

·        Name of Intermediate or API

·        Batch Number

·        Date of release

·        Expiry Date or Retest date as applicable

·        List of Test performed with acceptance criteria and the result obtained

·        Dated and signed by authorized personnel

·        Name address and telephone number of the original manufacturer

Note: If Analysis is done by repacker or reprocessor, name, address and telephone no. of repacker or reprocessor should be mentioned on COA with the reference to original manufacturer.

            If new certificate are issued by or on behalf of the repacker or reprocessor, agents or brokers, the certificate should mentioned name address and telephone no. of the laboratory that performed the analysis. Reference to the name and address of the original manufacturer and to the original batch certificate copy should be attached.

Validation of Analytical procedure

Analytical method should be validated unless the method used is included in relevant pharmacopeia or other recognized standard reference. The analytical method should be validated on the qualified equipment. However the suitability of all testing method used should be verified under the condition where the method is used and should be documented. In case there is any modification in the validated analytical it should be documented and complete record should be maintained.

Stability Monitoring of APIs

·     Stability Monitoring is required for API.

·     Stability Monitoring is an ongoing testing program to monitor the characteristic of the             API and to confirm appropriate storage condition and retest or expiry dates.

·     The procedure for stability testing should be validated and documented.

·      Stability Sample should be stored in container similar to the market container.

·   The first three commercial batches should be placed for stability to confirm retest and            expiry dates but if the data is available from previous studies that API is stable for at least    two years then fewer batches are acceptable for stability keeping.

Expiry/Retest date

If an intermediate is transferred outside the control of manufacturer’s material management system and an expiry or retest date is assigned can be in form of published data or test result.

The expiry or retest date of the API & intermediate should be based on evaluation of data derived from stability studies. Usually a retest data is used not an expiry date. When the commercial production is not initiated the expiry or retest dates can be based on the pilot scale production if:

·   The method and procedure simulates the final method and procedure of the commercial manufacturing scale.

·    The quality of the final product is equivalent to the material made on the commercial scale. 

Reserve/Retention sample:

Reserve/Retention sample are one and the same thing. These are kept for potential evaluation of the quality of batches of API. The sample should be kept either one year after the expiry date or for 3 years after the distribution of batches, whichever is longer. Similar packaging system should be used in which the API is dispatched or in packaging system which is more protective. The quantity stored should be equal to at least two full compendial analysis or two full specification analysis (in absence of pharmacopeia monograph)

Author – Anshu Yadav

Manager QA at Sharp Mint Limited.

Qualification: Masters in Industrial Biotechnology Management from Lille Catholic UniveersitySpecialization in QHSE in food and Pharmaceutical Industry.

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