Easy Learning ICH Q7-Part 1

The series is to comprehend Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients-ICH Q7

Total Section/Chapters are 20 where 1st and 20th Chapters are Introduction and Glossary

Pharma Terminology-Easy Learning

General Terminology of Pharma

1. Active Pharmaceutical Ingredient (API) and Excipient:

A drug comprises of two portions: API and Excipient. An excipient is the inert portion of the drug whereas API is the chemically active portion. Chemically active portion refers to the part of the drug which created the desired effect in the body.

2. Change Control:

The systematic approach to managing all changes made to a product or systems. The purpose is that all changes identified, reviewed, approved, archived and very well evaluated.

3. Raw material:

A raw material refers to a starting material, reagents, processing aids or solvents that are used to manufacture an API or an intermediate.

4. Impurity:

Any undesired entity present in any component of an API or Intermediate.

5. Intermediate:

An intermediate is a material that is produced during the manufacturing of API that undergoes further molecular change or processing to become an API. This is to be noted that as the intermediate is produced during the manufacturing of an API, the manufacturer shall decide the point where the initiation of API takes place.

5. Manufacturing:

Manufacturing in ICH refers to all the operation including receipt of material, production, packaging, repackaging, labeling, relabeling, storage, dispatch. It also quality control, release and all the other related control.  

6. Sampling:

Sampling is a technique in which a predefined quantity is taken from the whole lot for the purpose of analysis.The result of the analysis decides the fate of the whole lot.

The GMP Systems (General Requirement)

Every pharmaceutical manufacturer is responsible for establishing a GMP system in his manufacturing industry. In order to maintain an established framework of GMP system in theThe most essential requirements for maintaining good manufacturing practices in pharmaceutical industries is to have a strong system for

• Personnel
• Premises 
• Equipment
• Standard operating procedures 

Menthol Crystals-MSDS

1.        Product Identification

Product Name	Menthol Crystal Levo Natural
CAS No.	2216-51-5
EINEC No.	218-690-9
Molecular Weight	156.3 g/mole
Molecular Formula	C10H20O
Other Name	Menthol Crystal, Levo Menthol
Recommended Use	Flavouring substances, food additives
Pharmacopoeia	USP, EP, BP, JP, IP

Data Integrity-PART A

The data integrity has turned into an intense issue which is bringing association a terrible name during regulatory inspection. The administrative body trusts that the organisation where the information is precise, reliable and accurate and follow the regulatory guidelines and SOPs are working legitimately.

Management Reviews

To bring coherence in organisational functioning as also to determine operational performance, the top management of the company reviews the system performance regularly discussing all relevant issues so as to achieve performance improvement. A system of internal communication has also been established.

SOP ON REPROCESSING

1. OBJECTIVE

To describe the procedure for reprocessing of intermediate or API, which does not confirm to the standards or specifications.

Common terms used in API and Food Industries

In this article terms are defined which are commonly used in the API and food industries:

1. Deviation: 

Departure from an approved instructions or established standards.

[Instructions or standards are commonly specified in Standard operating procedure and Technical Instruction. Also Deviation is related to the systems not the product. ]

Flow diagram to handle Deviation

DEVIATION HANDLING AND MANAGEMENT

ALSO READ

Deviation Control And Management

SOP on Rework

1.0            OBJECTIVE

1.1  To define the standard operating procedure for the rework of Intermediate/API.

2.0            RESPONSIBILITY

2.1            Head Quality Control

2.2            Head Quality Assurance

2.3            Head Production

3.0            PROCEDURE

3.1            Definition of rework

3.1.1     Subjecting an intermediate or API that does not conform to  standard or specifications to one or more processing steps that are different from the established manufacturing process to obtain the acceptable quality intermediate or API.

3.2     Whenever a product is found out of specification or non conform, depending upon the nature of failure, a discussion is held between QA, Production, QC and R&D to determine the following:

 3.2.1       Reason for failure and investigation there off.

 3.2.2    Whether the batch is to be reprocessed or reworked to bring it up to the specification.

3.2.3 Whether stability study will be required?

3.2.4 Whether any specific controls to be exercised during rework in case it is to be reworked.

3.3       Based on the outcome of this discussion if rework is recommended then following procedure is adopted.

3.4    Based on the area of non-compliance, production Incharge determines reworking program or method of non conforming batch/material in consultation with quality assurance, quality control and if needed be with R & D.

3.5            It is also determined whether the situation is likely to occur again.

3.6         If it is found to be one –off situation proper technical study is undertaken for the efficacy of the rework protocol in achieving the rework objectives.

3.7          This protocol is adopted only if its technical soundness is fully established.

3.8     If however it is found that the non conforming situation is such that it may occur again, in that case the rework protocol is suitably validated before adoption.

3.9       The rework protocol is documented along with any control measure and records that are to be made to ensure compliance to the protocol.

3.10       A draft manufacturing record shall be prepared by production on the basis of recommendation of QA, QC and R&D.

3.11       Batch number shall be assigned as per Batch numbering SOP

3.12       All reworked batches shall be suitably identified so as to make it explicitly clear about their status as a reworked batch.

3.13  After the batch is reworked, the batch is analysed for it compliance with specifications.

3.14    A final test report is issued to production from QC after compliance of product with specification.

3.15    Comparison of impurity profile of each reworked batch against batches manufactured by the established process to be done.

3.16   Where routinely analytical method are inadequate to characterise the reworked batch, additional method should be used from approved accredited laboratory.

3.17       Adequate documents are prepared and archived with the BMR to describe the reason, steps taken and result.

3.18       The accelerated stability studies of reworked batches will be undertaken if the method used in unique and has not been studied for stability earlier.

3.19       The reworked batches may be released for commercial purposes if the quality of such batches is similar to the normal production batches.

4.0            ABBREVIATION

 4.1            NIL

5.0            ANNEXURES

 5.1            NIL

6.0            REFERENCE

6.1            ICH Q7 14.30,14.31,14.32

ALSO READ

1. Difference between rework and reprocess 

Difference between Rework and Reprocess

Rework and reprocess are very confusing terms. There has always been an uncertainty which procedure is to be followed. Below is an effort to define both in simple terminology

To understand rework and reprocess the first thing is to make it clear that the material which is supposed to be reworked or reprocessed are always the non-conforming products. It means while assessing the disposition of the nonconforming products it will be analysed whether the product shall be reworked or reprocessed.

Rework and reprocess are both not routinely done.

Rework will be done when the material or drug is not having the desired standards, as a result an extra work is done to bring it back to the set standard. This effort of extra work is different from the established validated manufacturing procedure. This is not always necessary that rework is applicable to each and every industry. Nevertheless every industry must have the procedure for rework and at least the middle management and higher are aware of the concept of "Rework".

On the other hand "reprocess is the repetition of the same predefined process."

Therefore, in order to decide whether the SOP of rework or reprocess is to be followed, the first thing which shall come to mind is that the product is a non conforming product. This shall be brought to the notice of higher management. The NCR committee shall decide the disposition of the material.

During decision of the disposition the committee may decide that the material may again follow the same validated procedure or a procedure which is different from the established procedure.

If the same validated procedure is followed than the material is considered to be reprocessed on the other hand if different procedure is followed than the material is said to be reworked.

AUTHOR: ANSHU YADAV

anshuyadav.icgian@gmail.com

quallpharmaconsultancy@gmail.com

Good Trade and distribution practices for pharmaceutical starting material

The responsibility of a pharmaceutical handler is higher than other manufacturers as the quality of the pharmaceutical products may severely affect the health of the patients and sometimes may even cause death. Every manufacturer, distributor and traders shall follow good trade and distribution practices and shall do risk assessment of there procedure and prctices to maintain the original quality of their products.  Also the starting material which is added in the pharmaceutical product shall also be included in the scope of risk assessment

The risk during storage, trade and transports are generally similar to those of manufacturing environment. The risk such as packaging, repackaging, labelling, relabelling, storage, distribution and record keeping practices can lead to a substandard drug. 

How to initiate a QRM process

Traditionally Hazard analysis and critical control point (HACCP) was adopted to do the risk assessment, Recently quality risk assessment is followed that is more relevant to the pharmaceutical industries. The guideline on Quality risk assessment to protect patient in terms of quality safety and efficacy of medicines.

In QRM a systematic science based decision making with respect to risk shall be considered. To intiate the QRM the problem shall be identified including possible risk. Detailed information shall be gathered which can lead to potential hazard or have harmful effect on human health and is relevant for the risk assessment

Quality Risk Management

The pharmaceutical industries are considered to be the most critical industry as the substandard medicines may put the life of patients who are consuming these products at risk.  

There are different regulatory authority who keeps an eye on the pharmaceutical industries.. these regulatory authorities include not only Indian authorities but also authorities of those countries where the pharmaceutical manufacturers  are dispatching  there products.

Difference between Drug and medicine

Drug and Medicines are generally considered as identical though there is difference between the two terms.

Drug - is a substance that creates hallucination or a stimulant.

Medicine - is a substance which is taken for treatment of any disease. Medicine is also considered as science.

SOP on cleaning on hose pipe

Below is the standard operating procedure to clean the Hose pipes. In some manufacturing companies hose pipe is also known as flexible pipe.

How to plan a Self inspection or Internal Audit

Internal audits are important within the manufacturing facility to recheck the existing system and to give assurance that an organisation's internal controls are .operating effectively.

Six Brand of turmeric added to recall for excessive lead.

A New Jersey company has expanding its recall of ground turmeric nationwide. Excessive lead, which is particularly dangerous for pregnant women, infants and children has been confirmed in the spice.

For more information Visit website

http://www.foodsafetynews.com/2016/08/six-brands-of-tumeric-added-to-recall-for-excessive-lead/#.V6p8JPl961t

Procedure on Good Recording Practices

OBJECTIVE

To lay down a procedure for Good Recording Practices.

RESPONSIBILITY

Personnel - All departments.
Heads – All Departments

PROCEDURE

• Personnel shall make on line entries in the documents.
• The entries made by the operating personnel shall be checked and signed by the    supervising       personnel.
• No entry shall be over written.
• If anything is wrong do not over write it.

HOW TO DETERMINE QUALITY IMPACT ON THE PRODUCT

While determining the quality impact of any event identified in the manufacturing of an API, the below aspect shall be studied but not limited to

1. Does it affect the final application or use by the customer?
2. Does it affect the storage condition of the product?
3. Does it affect the packing of the product?
4. Does it affect the transportation of the product?
5. Does it affect the Human safety?
6. Does it affect the Critical control point?
7. Does it affect the stability of the product?

If yes to any of the above questionnaire than there is quality impact on the API product,
If No to all the above questionnaire than there is no quality impact on the API product.

In case there is a quality impact the disposition of the product is to be decided.

Readers may contact the author at anshuyadav.icgian@gmail.com.

Related Articles 

How to initiate QRM process

Quality Risk Management

AUTHOR: ANSHU YADAV

quallpharmaconsultancy@gmail.com

anshuyadav.icgian@gmail.com