Saturday, October 8, 2016

Menthol Crystals-MSDS

1.        Product Identification

Product Name
Menthol Crystal Levo Natural
Molecular Weight
156.3 g/mole
Molecular Formula
Other Name
Menthol Crystal, Levo Menthol
Recommended Use
Flavouring substances, food additives

Wednesday, October 5, 2016

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.

Friday, September 30, 2016

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.

Monday, September 19, 2016



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

Tuesday, September 13, 2016

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. ]

Wednesday, September 7, 2016

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


Tuesday, September 6, 2016

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.


Friday, September 2, 2016

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. 

Friday, August 26, 2016

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

Wednesday, August 24, 2016

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.

Tuesday, August 23, 2016

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.

Saturday, August 13, 2016

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.

Thursday, August 11, 2016

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.

Wednesday, August 10, 2016

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

Monday, August 8, 2016

Procedure on Good Recording Practices

To lay down a procedure for Good Recording Practices.

Personnel - All departments.
Heads – All Departments

  • 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.

Friday, August 5, 2016


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

Related Articles 


Tuesday, August 2, 2016

US FDA announces approval for generic Glumetza

Sun Pharma  today announced that one of its subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Glumetza, Metformin Hydrochloride extended release tablets 500 mg and 1000 mg.
These Metformin Hydrochloride extended release tablets are therapeutic equivalents of Santarus Inc.’s Glumetza 

For more information view website

Monday, August 1, 2016


The aim of the document is to contribute to the understanding of a quality risk management approach in the handling of deviations from practical perspective as per WHO expectations on the matter.

The document is in line with documents like ICH Q10 Pharmacuetical Quality System, ICH Q9 Quality Risk Management like WHO, FDA and EU requirement.


  • Deviation: Any departure from an approved instruction or established standards [Glossary of ICH Q7 –Good manufacturing guide for active pharmaceutical ingredients]
  • Event Categorisation
    • Identification of an Event- Anything that happens or takes place, especially important for notification.
    • The decision tree described in the Flow diagram Diagram  is a simplified risk assessment that answer the following questions when an event is encountered:
      • Effect on the product attribute
      • Effect on manufacturing operational parameter.
      • Effect on the Product quality.
      • Contradict or omit specified requirement.
      • Effect on the cGMP
  • The specified requirements mentioned in may be from any of the following:
    • Standard Operating procedures that may cover any subject.
    • Inspection and testing protocols.
    • Customer specified requirements.
    • Regulatory requirement.
    • Technical instruction.
    • Specified parameters written in forms and formats, log books and registers.
    • HACCP plan.
    • Drawing
    • Specifications
  • Incidents
    • If the answer is NO for questions and above, the event may be considered an Incident.
    • On the contrary, if any of the answer for questions and is YES the event shall follow the path towards a deviation category.
  • Deviation
    • A deviation is a situation that has occurred either in a planned or unplanned manner. It may be on a product or a process.
      • Planned Deviation: Any deviation from a documented procedure or specified requirement adopted deliberately as a temporary measures.
      • Unplanned Deviation: Any deviation occurred in an unintentional manner due to system failure, equipment breakdown, human error or any unforeseen circumstances.
        • Minor Deviation - When the deviation does not affect any quality attributes, an operational or manufacturing parameters, or an equipment or instrument associated with the process, it is considered as Minor deviation.
        • Major Deviation- When the deviation affects the quality attributes, an operational or manufacturing parameters, or an equipment or instrument associated with the process, of which the impact to personnel/environment is unlikely, the deviation is categorise as Major deviation.
        • Critical Deviation- When the deviation affects the quality attributes, an operational or manufacturing parameters, or an equipment or instrument associated with the process, of which the impact to personnel/environment is highly probable is categorise as critical deviation
  • Event Handling
    • Identification of an Event- Anything that happens or takes place, especially important for notification.
    • Whenever such event comes to notice use format no. F01 (Mail to if format is required) to identify whether it is an incident or Deviation and to classify it as planned or unplanned deviation.
    • If it is an unplanned deviation than use format No F02 (Mail to if format is required)  to classify it as minor, major or critical.
    • If it is a planned deviation than use format No F03 (Change control format)
    • If it is and minor deviation/ incident than use format No F04(Mail to if format is required)
  • Steps to handing Minor Deviation/Incidentt:
    • Description of an Event
    • Correction
    • Efficacy and Conclusion
    • Recording
    •  Monitoring
Minor deviation shall be reviewed by Manager QA, recommended by department HOD and approved by Head QA

  • Handling major deviations/critical deviations
    •  Description of an event
    •  Correction
    •  Efficacy and Conclusion
    • Root cause investigation 
      • Investigation shall be done by using  5 why technique etc.
      • An investigation report shall be generated which shall have the below contents but not limited to :
        • Reason for investigation(what event or finding prompted investigation, how and when happened)
        • Describe what happened(when and where)
        •  Identify other batches/lots affected
        •  Identify root cause
    • Quality Impact
      • The Quality impact shall be assessed by Quality Risk Management SOP. If there is a quality impact the product is considered as non-confirming product.
      • Recommendation from department head, approval from Head QA and authorization by Director TQM.
      •  Validation impact/supporting document.
      • Assessment of validation impact (Shall be done by Departmental Head/Head QA and Director TQM)
      • CAPA
      • Efficacy of corrective action
      • Conclusion
  Note:      Major/Critical deviation shall be reviewed by Manager QA, recommended by department HOD and approved by Head QA and authorized by Director TQM.

  •  Handling of planned deviation
    • Description of an event
    •  Justification for requirement of planned deviation
    •  Quality Impact
      • The Quality impact shall be assessed by Quality Risk Management SOP. If there is a quality impact the product is considered as non-confirming product 
      •  Validation impact/supporting document.
      •  Assessment of validation impact.
      •  CAPA
      •  Efficacy of corrective action
      • Conclusion
      • Recording
      • Monitoring
Note:Planned deviation shall be reviewed by Manager QA, recommended by department HOD and approved by Head QA and authorised by Director TQM.

  • QA shall retain the records irrespective of the approved / reject status of the deviation report and a photocopy of the same shall be filed with the subjected batch manufacturing / packing record/analytical reports.
  • Wherever a deviation could affect multiple batches, e.g. due to equipment or facility failure or material or process deviation report, a photocopy of the same shall be filed with the subjected batch manufacturing / packing record / analytical report.
  • If it is found that the deviation occurred on account of a faulty procedure or process, action shall be taken to amend the concerned document under company’s document change system for necessary amendments to the affected documents.
  • QA personnel shall maintain the deviation log, department wise, and year wise as per the Deviation Control Log (Mail to
  • Deviation/INCIDENT control numbering system (For details mail to

If there are any query, questions or suggestion related to the article, please mail back to


Friday, July 29, 2016

Gowning Procedure

1.0              OBJECTIVE

1.1              To outline the procedure for personal cleanliness for entry into high risk zones.

2.0              PROCEDURE

3.1              Enter into the change room.

3.2        Remove he accessories like mobile phones, wrist watches, rings, wrist bands, ornaments or jewellery.

3.3            Before entering, personnel shall either cover their street shoes with disposable covers or wear footwear that are earmarked for this purpose.

3.4              Move to the other side of the crossover bench.

3.5              Wash hands thoroughly.

3.6              Wear head gear to cover head.

3.7              Wear the mask and cover the beard.

3.8             Wear the gown. 

3.9              Take one or two drop of hand sanitizer on palm and rub it to evaporate it.

3.10          Enter the high risk zone.

3.11     Person shall remove their gowns and keep them in the change room before going outside the area.

3.12       Remove all the gowns whenever going out of the high risk zone even for a short period.

3.13          Follow entire procedure all over again whenever you re-enter the high risk zone.

3.14          Use neck chain for the spectacles or safety eye glasses.  

3.15          All the gowns shall be collected in basket and sent to the laundry at the end of the day.

4.0              ABBREVIATIONS

4.1              NIL

5.0              ANNEXURES

5.1              NIL

6.0              REFERENCE

6.1              NIL

            Detail gowning procedure and board are available if users/readers require the same. If there are any query/questions or suggestions related to the article, readers are requested to mail their query at