schiff gmp compliance key points

8/12/2019 Schiff GMP Compliance Key Points

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KEY POINTS FOR

GMP-PRODUCTIONCOMPLIANCE

KEY POINTS FOR GMP

ROBERT SCHIFF, PHD, RAC, CQA

PRESIDENT AND CEO

SCHIFF &COMPANY

1129 BLOOMFIELD AVENUE

WEST CALDWELL, NJ 07006

973-227-1830

ESTABLISHED IN 1982


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NEED FOR GMP REGULATION

Adulteration Product not made according to master record

Misbranding Labeling not correct

Claims not appropriate

Safety Too much, too little, not sterile

Effectiveness Product does not work

WHAT IS COMPLIANCE

Conformity

Obedience

Fulfillment


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GMP COMPLIANCE

DRUGS

21 CFR 211

DEVICES

21 CFR 820

BIOLOGICS

21 CFR 211 and 600

FOOD 21 CFR 110

SUPPLEMENTS

21 CFR 111

ICH GUIDELINES

ICH Q Series

Q1A-Q1F

Q2A-Q2B

Q3A-Q3C

Q4

Q5A-Q5E

Q6A-Q6B

Q7A

Q8-Q10


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PRODUCTION

21 CFR 210.3 (12)

Manufacture, processing, packing, or

holding of a drug product includes

packaging and labeling operations, testing,

and quality control of drug products.

QUALITY CONTROL

21 CFR 211.22 (a) There shall be a quality control unit that shall have the

responsibility and authority to approve or reject all

components, drug product containers, closures, in-process

materials, packaging material, labeling, and drug products,

and the authority to review production records to assure

that no errors have occurred or, if errors have occurred, that

they have been fully investigated. The quality control unit

shall be responsible for approving or rejecting drug products

manufactured, processed, packed, or held under contract byanother company.


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DOCUMENTATION

Standard operating procedures

Quality and/or operations manual

Validations and verifications

Qualifications

Corrective and preventive actions

Oos and deviations

THE MASTER RECORD

Bill of materials

Approved vendors

Equipment needed

Procedures in detail

Raw material qc

In process qc

Finished goods qc Labels

Release procedure


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BUILDINGS AND FACILITIES

Receiving area

Security

Quarantine

Inspection

Sampling

Testing

Rejected material handling


CONTINUED

Warehouse

Arrangement

Labeling of items for status

Red, yellow, green

Segregation of goods

Separate raw, in process and finished

Separate regulated from non-regulated

Neatness counts Eliminate possibility for error


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CONTINUED

Manufacturing area

Staging

In-process storage

Line clearance

Blending

Filling

Packaging


CONTINUED

Shipping area

Holding area prior to release

Storage of released goods

Record keeping

Security


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CONTINUED

Utilities Water system

Testing routinely

Lighting

Maintenance

Pest control Record keeping

Verification

EQUIPMENT, CONTAINERS AND

PRODUCTION DOCUMENTS

Equipment

Design

For which it was intended

Location

Cross draft

Open doors

Materials

Extractables

Lubricants and coolants

Jacketed equipment


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PRODUCTION DOCUMENTSCONTINUED

Equipment maintenance Mechanical equipment

Precision equipment

Automatic equipment

Electronic and computers

Calibration

Cleaning

Log books and records


PRODUCTION DOCUMENTSCONTINUED

COMPUTERS

21CFR PART 11

VALIDATION OF COMPUTERS THAT

DRIVE OR RECORD PRODUCTION

PROCESSES SOFTWARE VALIDATION REQUIRED


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PRODUCTION AND DISTRIBUTION

CONTROLS

Raw materials

Receiving and quarantine

Inspection and testing

Approved and released

Rejected

Rework areas


CONTROLS CONTINUED

Manufacturing

Preparation of equipment and sops

Assignment of control number

Records and entries

In-process testing

In-process storage

Batch adjustments


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CONTROLS

Labeling and packaging Storage of labels

Label controls

Label accountability

Packaging lines

Packaging materials

Packaging equipment

Preparation of equipment

Sec. 211.84 Testing and approval or

rejection of components, drug productcontainers, and closures.

(a) Each lot of components, drug

product containers, and closures shall

be withheld from use until the lot has

been sampled, tested, or examined, as

appropriate, and released for use by thequality control unit.


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211.84 Continued

b) Representative samples of each shipment

of each lot shall be collected for testing or

examination. The number of containers to be

sampled, and the amount of material to be

taken from each container, shall be based

upon appropriate criteria such as statistical

criteria for component variability, confidence

levels, and degree of precision desired, thepast quality history of the supplier, and the

quantity needed for analysis and reserve

where required by 211.170.


CONTROLS

Shipping and carton labels

Final testing

Delivery records


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SHIPPING AND HANDLING

Packaging

Temperature control

Temperature monitoring

Air versus ground shipping

Sample receipt

Data logging

STABILITY, EXPIRATION

DATING AND VALIDATION

Stability establishes dating

Stability testing is validation

Validation of expiration

Poolability of slopes

Poolability of intercepts

Confidence intervals


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VALIDATION AND QUALIFICATION

INTERPRETING REGULATORY

REQUIREMENTS

What are the differences between validation

and qualification

Equipment is qualified

Methods and processes are validated

Before a method can be validated the

associated equipment must be qualified

WHAT TO DO

Qualification and Validation

Equipment

Processes

Water

Clean Rooms

Facilities

Cleaning


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THINGS TO REMEMBER

Review on a Daily Basis

Take Notes

Differentiate Between Guidelines andRegulations

Inform Management of Changes

Know Your Source

Do Not Always Accept on the Basis of

Certification Never Accept on Supposition

schiff gmp compliance key points

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