pharma uptoday mm: volume 1 issue april 2014

About Pharma Uptoday :

The "Pharma Uptoday" Newsletter initiated on 18-Jul-2013 to refresh the subject,

update the guidelines, regulations & current happenings.

This website is restricted to people in Drugs & Pharmaceutical industry who are

enthusiastic to know about current happenings and learn and implement the

same. It doesn't include the topics related to Pre-clinical, Clinical, Biotech /

Biosimilar, Medical device (with some exceptions).

This Group and the Website is initiated to share the knowledge, to minimise /

avoid 483's, Warning letters, deviations etc as “Together we can make Global

Pharma excel”.

Updates in this Newsletter include:

• Updates & News on Warning letters, 483s, US FDA, GMP etc.

• Literature & Topic Related to Pharma / General requirement

• Presentations, Webinars, Guidelines, Books, Articles etc.

Message from the Editor

Highlights of Pharma Uptoday :

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• Number of Posts till date : 453

• Regular topics include: GMP, Article of the week, 483s, Regulations,

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Inside This Issue

1 Message from the Editor

2 News Uptoday

3 News Uptoday

4 News Uptoday

5 New Guidelines

6 New Guidelines

7 New Guidelines

8 Audit Findings

9 Audit Findings

10 Audit Findings

11 Audit Findings

12 Regulations of the Month

Together we can make

Global Pharma excel.

PHARMA UPTODAY

VOLUME 1 ISSUE APR 2014

10-Apr-2014

PHARMA UPTODAY

Adjusted fees for applications to European Medicines Agency from 1 April 2014

The European Medicines Agency reminds applicants and marketing-authorisation holders that adjusted fees will be coming

into effect on Tuesday 1 April 2014.

Every year, the Agency adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year. The

European Commission is currently in the process of adopting a regulation adjusting the fees payable to the Agency in line

with the 2013 inflation rate. Although the final adjustment is not yet known, the Agency expects its fees to increase by around

1.5%.

The Agency will publish full details of the revised fees at the end of March, once the European Commission has adopted the

regulation and published it in the Official Journal of the European Union and the Agency's Management Board has reached

a decision on its implementation.

All applications received by 31 March will be charged at the current fee and reduction rates. Applications received after

that date will be charged the adjusted fees and be subject to the revised reduction rates, where applicable. For scientific

advice and protocol assistance, the cut-off date will be the date of validation of the request for advice.

FDA-EMA extends pilot program of the QbD parallel-assessment

The FDA and the European Medicines Agency have agreed on a two-year extension of the joint pilot program for the parallel

evaluation of quality-by-design applications beginning April 1, 2014.

FDA and EMA began the joint venture in March, 2011, to share knowledge, ensure consistent adherence to international

guidelines related to QbD and promote the availability of pharmaceutical products of consistent quality throughout the

European Union and the U.S.

QbD is an approach to ensuring consistent drug quality through statistical, analytical and risk-management methodology in

drug design, development and manufacturing.

The three-year pilot program has created inter-agency agreement on a wide range of QbD topics, culminating in the

publication of two question-and-answer documents for the benefit of industry and agency regulators, while spurring joint

research efforts on QbD-related topics.

In spite of these successes, the agencies have agreed that there remain QbD areas that warrant additional inter-agency

harmonization, resulting in the decision to extend the pilot. The agencies expect to publish more documents in 2014.

TGA Upgraded over-the-counter medicines online application system

From 9th April 2014, over-the-counter medicines applications will be submitted through an upgrade to the OTC medicines

online application system.

Applications will be easier to submit and process and industry will benefit from this reduction in regulatory burden.

Access to the upgraded system will continue to be through the eBusiness Services website.

This upgrade is part of the staged implementation of the harmonisation of OTC medicines business processes in Australia and

New Zealand.

News Uptoday

PHARMA UPTODAY

News Uptoday

FDA bans imports from Sun Pharma plant in India

The U.S. Food and Drug Administration (FDA) has banned imports from Indian generic drugmaker Sun Pharmaceutical Industries

Ltd's plant at Karkhadi in the western state of Gujarat, in the latest quality blow for India's drug sector.

The FDA has imposed a rash of regulatory sanctions on Indian generic makers in the last year, triggering concerns about the

quality of the medicines supplied by the $14 billion industry to countries including the United States, the biggest market.

Torn documents, partially destroyed raw data showing undesirable results and unclean toilets were among the reasons cited by

the US drug regulator for the ban it imposed last month on a Gujarat-based facility of Sun Pharma, the largest Indian drugmaker

by market capitalisation.

"Drug products failing to meet established specifications and quality control criteria are not rejected," said a form 483 issued to

the company, which spell out violations as observed by US investigators at the Karkhadi facility during their audit in November

2013.

Analysts had pointed out that the import alert by the US Food and Drug Administration (FDA) on the facility was unlikely to cause

any significant financial impact but said they awaited clarifications on the nature of violations.

"We identified multiple torn/partially destroyed raw data cGMP (current good manufacturing practices) manufacturing and

quality records. Our review of these records identified the practice of maintaining duplicate versions of cGMP raw data records.

Undesirable data was found to be changed in the official versions in order to meet specifications," said the FDA inspection

report.

"We have sent our response to the FDA and given that the facility now has an import alert, it's clear that the FDA does not

agree with our view. In this process, we have learnt and have resolved to work on further strengthening our systems and

controls," a spokesperson told.

With regard to the torn documents and partially destroyed data, the company said it has put remedial measures in place. "The

applicable SOP (standard operating procedure) in this case was not adhered to for which appropriate corrective action has

been taken," Sun said in an email.

"The reason this was not detected as part of our internal compliance checks is due to the equipment not being CFR (code of

federal regulation) compliant. We are now replacing this with CFR compliant equipment.

In addition, we are ensuring that equipment at all locations is CFR compliant. Also appropriate disciplinary action has been

taken." The report, which makes 11 observations on deviations from US prescribed quality standards, said the toilet for

manufacturing operators at the plant was in "total disrepair" and lists concerns about poor housekeeping.

"The two urinals present in the washing and toilet facility provided for quality control laboratory male employees were found to

drain directly onto the floor. Urine was found to be collected in and around an open drain. A strong smell of urine was observed

throughout your firm's quality control environment," said the report signed off by FDA investigators Peter Baker and Dipesh Shah.

The poor washing and toilet facilities have been fixed, Sun said. They also spotted a garbage dump in the perimeter of the

manufacturing area, apart from various forms of infestation. "Buildings used in the manufacture, processing, packing or holding

of drug products are not free of infestation by rodents, birds, insects and other vermin," the report said.

PHARMA UPTODAY

News Uptoday

Chinese API Manufacturers Zhejiang Jiuzhou Pharmaceutical, Zhejiang Zonebanne put on FDA Import Alert

Import Alert Name: "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"

Reason for Alert: *** Foreign inspections of pharmaceutical manufacturers are being performed. Detention without physical

examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current

good manufacturing practices (GMP's).

Detention without physical examination may also be appropriate when FDA receives information concerning inspections

conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement that FDA

concludes reveals conditions or practices warranting detention of either particular products or all products manufactured by a

firm.

DWPE of such firms remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed,

either by reinspection or submission of appropriate documentation to the responsible FDA Center. ***

Source : http://www.accessdata.fda.gov/cms_ia/importalert_189.html

FDA Reduces GMP Inspections by 40 Percent, Focuses on Imports

The FDA is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent in

favor of conducting more inspections overseas. The shift is part of a broader agency push to improve the quality of drugs

imported into the U.S. The change also brings the FDA closer to achieving its longtime goal of bringing parity to U.S. and foreign

inspections, so that foreign drug manufacturers would be as likely to be inspected as U.S.-based facilities.

The FDA plans to conduct 591 domestic good manufacturing practice (GMP) inspections in fiscal 2014 and 2015, down from

the 967 performed last year. The agency in turn hopes to perform 30 percent more foreign GMP inspections, conducting 843

inspections each year, up from last year’s 604. Companies will be chosen for inspection based on the agency’s risk-based

inspection model that grants leeway to high-quality companies. The FDA takes into account risk factors including Class I recalls

and adverse events, as well as compliance history, in applying the risk-based inspections model to its decision making.

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PHARMA UPTODAY

New Guidelines

FDA Unveils New Guidance on Reporting Post-Approval Changes.

A new guidance finalized by the US Food and Drug Administration (FDA) is meant to clarify which events and changes

sponsors of new and generic drug products need to report in their annual reports to FDA.

Under FDA regulations, changes to an approved new drug application (NDA) or abbreviated new drug application

(ANDA) must be reported to regulators. Depending on the impact, reports of the change must either be approved in

advance (Prior Approval Supplement), reported at the time of the change (Changes Being Effected-0 Day) or right

before (CBE-30), or on an annual basis.

Those reported in an annual report are those that have the least potential to affect a product's safety, efficacy or quality.

As FDA explains in its new guidance, CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports,

many changes reported to FDA are of little risk to the product, and therefore would be better suited to annual reports—

not supplements.

As such, FDA has compiled a new list of changes (Appendix A and B in the guidance) that companies can reference to

see if their post-approval manufacturing changes would be appropriate to report in an annual report.

"We expect NDA and ANDA holders to evaluate the specific change that they are planning to make in the context of

their particular circumstances to determine whether the proposed change would present a minimal potential to have an

adverse effect on product quality," FDA writes. "When a risk-based evaluation shows that the proposed change would

have a minimal potential to have an adverse effect on product quality, the change can be documented in the next

annual report."

The new guidance supersedes change reporting recommendations in all other guidance documents, FDA said.

The guidance also covers the basics of the changes that must be recorded in the annual report, including a list of the

changes, a summary of tests confirming the (non)impact of the changes, a description of the changes, and references

to products affected.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM217043.pdf

FDA Releases Guidance for Industry: Guidance on Antiviral Product Development — Conducting and Submitting

Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance


PHARMA UPTODAY

New Guidelines FDA Releases Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses —

Recommended Practices (Revised Draft Guidance)

This guidance describes the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on recommended

practices for drug and medical device manufacturers and their representatives to follow when distributing to health

care professionals or health care entities scientific or medical journal articles, scientific or medical reference texts, or

clinical practice guidelines (CPGs) that discuss unapproved new uses for approved drugs or approved or cleared

medical devices marketed in the United States. For the purposes of this guidance, these materials are generally referred

to as scientific and medical publications.


EMA publishes New Process Validation Guideline

Compared to the current Note for Guidance, the revision remains in its final version pretty difficult to read and rather

general. This is a marketing authorisation document, which is clearly addressed in the title and only applies to finished

dosage forms of chemical medicinal products for human and veterinary use but not for old ones, which are already

authorised and on the market. The introduction of a validation life cycle and the integration of continued process

verification (CPV) are completely new although this approach is already acquainted from ICH Q8. The "traditional

approach" remains accepted. Like in the Annex 15 draft the hybrid approach remains here in the final document

"nebulous". The idea to integrate modern elements from ICH Q8, Q10 (and Q11) into the document is clearly noticeable.

Yet, far less concrete references are made to ICH Q9.

A stronger overlap of the FDA Guidance would have been desirable. FDA's Guidance also deals with APIs and

biologicals, and the process validation life cycle runs like a thread through the whole FDA document. FDA's Guidance

also contains GMP aspects. The FDA Guidance explicitly addresses old products which should be integrated to stage 3

of the life cycle. Yet, there is another big difference. The revised document doesn't highlight statistical methods like the

FDA Guidance.

Before the finalisation, a comparison with the Annex 15 has been made which is a nice thing. This explains the long

period between the publication of the draft (March 2012) and that of the finalisation (February 2014).

What is significant for the GMP world? On the one hand almost nothing, on the other hand quite a lot: one may wonder

why? Direct references to the Annex 15 can be found with regard to the "ongoing process verification" and "concurrent

validation", which is almost nothing looking at the whole document. Moreover, validation in general is required to be

executed according to the GMP regarding "continuous process verification" and "change control"; these are the

essential parts of the document, and (almost) the complete document should therefore be seen from a GMP

perspective.

The new EMA guideline on process validation will apply by the end of August 2014.

PHARMA UPTODAY

New Guidelines FDA publishes Guidance for Industry: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological

Products

This draft guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research’s (CDER’s) and

the Center for Biologics Evaluation and Research’s (CBER’s) current thinking on allowable excess volume and labeled vial

fill size in injectable drug and biological products. Specifically, the draft guidance clarifies the FDA regulatory requirements

and recommendations pertaining to allowable excess volume in injectable vials and describes when justification is needed

for a proposed excess volume in these injectable drug products.

This guidance also discusses the importance of appropriate packaging sizes for injectable drug products and recommends

that labeled vial fill sizes be appropriate for the intended use and dosing of the drug product.


FDA published draft guidance, Bioavailability and Bioequivalence Studies Submitted in New Drug Applications or

Investigational New Drug Applications—also known as the NDA BA and BE Draft Guidance—is meant to clarify FDA's latest

views on complying with 21 CFR 320.

That section, "Bioavailability and Bioequivalence Requirements," calls for all applicants of full new drug applications (NDAs)

to either submit data measuring the in vivo bioavailability of a drug or data showing why BA data is unnecessary. It also

calls for any sponsor of an ANDA to submit data establishing bioequivalence between the generic drug and the drug it

references, known to FDA as the reference listed drug (RLD).

These data are crucial during various stages of FDA's regulatory approval process. For example, FDA will require any drug

seeking approval to submit BA and BE data. Similarly, once a drug is approved by FDA, the agency will require BE testing

after any major changes (such as to the manufacturing process) to ensure that the test drug product has not changed

relative to the approved reference drug product.

Another example is when a company is advancing a drug through investigational testing. Companies often make changes

to a drug product's manufacturing process during this time (known as scale-up changes), and testing is necessary to ensure

that a product hasn't changed.


FDA publishes Draft Guidance for Industry: Labeling for Human Prescription Drug and Biological Products Approved Under

the Accelerated Approval Regulatory Pathway

This guidance is intended to assist applicants in developing the INDICATIONS AND USAGE section of labeling for human

prescription drug and biological products for indications that are approved under the accelerated approval regulatory

pathway (hereafter accelerated approval) as defined in section 506(c) of the Federal Food, Drug, and Cosmetic Act

(FD&C Act) and 21 CFR part 314, subpart H, or 21 CFR part 601, subpart E. More specifically, this guidance focuses on

indications and usage statements for drugs approved on the basis of a surrogate endpoint or an effect on a clinical

endpoint other than survival or irreversible morbidity. This guidance also addresses labeling considerations for indications

that were approved under accelerated approval and for which clinical benefit subsequently has been verified and the

FDA terminates the conditions of accelerated approval under 21 CFR 314.560 or 21 CFR 601.46, or when the FDA withdraws

accelerated approval of an indication while other indications for the drug remain approved.


PHARMA UPTODAY

Audit Findings

483 Observations:

Akron Coating & Adhesives, Inc.

Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all

appropriate written specifications, without establishing the reliability of the supplier’s analyses through appropriate

validation of the supplier’s test results at appropriate intervals.

BASF Corp.

There was a failure to handle and store components at all times in a manner to prevent contamination.

Mylan LLC

Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the

manufacture, processing, packing or holding of a drug product.

University of Iowa Pharmaceuticals

Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its

specifications did not extend to other batches of the same drug product and other drug products that may have been

associated with the specific failure or discrepancy.

Brookfield Prescription Center, Inc., dba MD Custom Rx

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not

established, written and followed.

Millipore UK Ltd.

Effective contamination control has not been demonstrated.

Everglo Natural Veterinary Services, Inc.

Batch production and control records are not prepared for each batch of drug product produced and do not include

complete information relating to the production and control of each batch.

Specialty Medicine Compounding Pharmacy

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not

established, written and followed.

Aurolife Pharma, LLC

There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications

whether or not the batch has been already distributed.

Pharma Pac, LLC

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and

control records or other records are instituted only by authorized personnel.

Baxter Manufacturing S.p.A.

Manufacturing equipment are not adequately maintained to prevent contamination of manufactured products and

manufacturing personnel are not adequately trained in the use and assembling of manufacturing equipment.

Bisco, Inc.

Process validation activities and results have not been documented.

PHARMA UPTODAY

Audit Findings Non-compliance Reports:

VAKOS XT a.s., Czech Republic:

VAKOS XT, a.s. produced and exported to Slovak Republic sterile medicinal product MULTIPEN HD. VAKOS XT, a.s. is not

autorised to manufacture and release sterile medicinal products. The pharmaceutical quality system in the company is

dysfunctional and VAKOS XT, a.s. does not meet GMP requirements.

Smruthi Organics Limited, Solapur, Maharashtra, India:

[Critical 1] Manipulation and falsification of documents and data were observed in different departments ;

[Critical 2] Some Corrective and Preventive Actions, related to deficiencies raised during the previous inspection were

not satisfactorily addressed ;

[Major 1] An out-of-specification result obtained for an In-Process Control, performed by TLC, was considered as

compliant by the analyst ;

[Major 2] The documentation practices for process validation were found unacceptable ;

[Major 3] The company's approach and understanding of the GMP requirements for the re-qualification of the

equipment was found to be unsufficient ;

[Major 4] There was no raw data available in the Quality Control laboratory for the verification of compendial analytical

methods.

IND-SWIFT LIMITED, Punjab:

It was not possible to confirm the validity of stability testing data. Several falsified and inaccurate results had been

reported in long term stability and batch testing.

Discrepancies between electronic data and those results formally reported were identified.

Established processes to verify data accuracy and integrity had failed and there had been no formal investigation

raised by the company.

The company provided commitments to address the data integrity concerns and initiated a wider review of quality

critical data. Additional discrepancies were identified in process validation and release data.

During on-going communications with the licensing authority regarding the data review, the company failed to disclose

data integrity issues for all products. No satisfactory explanation was given for this discrepancy.

Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm390278.htm

PHARMA UPTODAY

Audit Findings

Non-compliance Reports: (Continued)

• [Critical] The manufacturing and cleaning operations during and between the campaigns of 15 APIs, whose 2 are used in

injectable dosage forms and one is an ectoparasiticide (Fipronil), are not traceable. Many records are missing.

• [Critical] Cleaning procedures are not detailed to enable operators to clean each piece of equipment in a reproductible

and effective manner.

• Cleaning procedures of the critical pieces of equipment used after final isolation of pure APIs are not validated.

• Analytical methods by TLC used for cleanliness verification are not validated. Complete records of raw data generated

during cleanliness tests by thin layer chromatography are missing. Moreover, cleanliness tests are not conducted for

plates of dryers used for APIs.

• The other major findings were mainly related to the manufacturing of an ectoparasiticide for veterinary use (Fipronil) in

multi-products manufacturing area and equipment without any study based on QRM principles regarding cross-

contamination and containment, highlighting the non compliance status to the GMPs.

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PHARMA UPTODAY

Audit Findings

Warning letters:

Smruthi Organics:

Failure to maintain complete and accurate laboratory test data generated in the course of establishing compliance of

your APIs to established specifications and standards.

Failure to maintain and make available for inspectional review production and control records for currently marketed

APIs.

Inadequate investigations of critical deviations or a failure of a batch to meet its specifications or quality standards.

There was no record made describing the reason for the replacement of the original logbook.

you are unable to recover the integration parameters used for API assay and impurity tests.

Reassess your analytical test method validation and verification activities and identify those methods which do not have

complete supporting data

Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm390278.htm

Canton Laboratories, Vadodara:

• Failure to perform laboratory testing of APIs to ensure conformance to specifications and to accurately report results

on Certificates of Analysis (CoA)

• Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established

specifications and standards.

• Failure to ensure equipment is cleaned in a reproducible and effective manner to prevent contamination of a

material that would alter the quality of the APIs.

• Failure to ensure that APIs are produced according to pre-approved instructions and that batch production records

include complete information pertaining to the production of each batch.

• Failure to properly investigate customer complaints.

• Failure to properly investigate out-of-specification results.

• Failure to follow your Master Validation Plan for process validations or equipment calibrations.

• Failure to provide adequate resources to the quality unit.

• Failure of your quality unit to properly review production records and detect instances where testing was not

performed to support your company’s certifications on your COAs.

• Failure to perform appropriate stability studies for product currently in the market.

• Failure to establish an impurity profile for product currently in the market.

Source : http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm387960.htm

PHARMA UPTODAY

§ 211.142 Warehousing procedures.

Written procedures describing the warehousing of drug products shall be established and followed. They shall include:

(a) Quarantine of drug products before release by the quality control unit.

(b) Storage of drug products under appropriate conditions of temperature, humidity and light so that the identity,

strength, quality, and purity of the drug products are not affected.

§ 211.150 Distribution procedures.

Written procedures shall be established, and followed, describing the distribution of drug products. They shall include:

(a) A procedure whereby the oldest approved stock of a drug product is distributed first. Deviation from this requirement

is permitted if such deviation is temporary and appropriate.

(b) A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if

necessary.

Subpart I--Laboratory Controls

§ 211.160 General requirements.

(a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control

mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test

procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and

reviewed and approved by the quality control unit. The requirements in this subpart shall be followed and shall be

documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test

procedures, or other laboratory control mechanisms shall be recorded and justified.

(b) Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards,

sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process

materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

Regulations of the Month

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pharma uptoday mm: volume 1 issue april 2014

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