PHDDS (Lab) | Module 2.1: CURRENT GOOD MANUFACTURING PRACTICE (cGMP) & CURRENT GOOD COMPOUNDING PRACTICE (cGCP)

US-FDA Administrative Order no. 220 s.1974

Among the guidelines promulgated by the _______________________________ on current good manufacturing practice made the strongest impact on the drug and cosmetic industry.

1963

This administrative order was patterned after the guidelines developed in ____ by the US-FDA with the participation of drug components

current Good Manufacturing Practice

Also referred to as 'cGMP'

current Good Manufacturing Practice

is a term that is recognized worldwide for the control and management of manufacturing and quality control

current Good Manufacturing Practice

is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods

current Good Manufacturing Practice

is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products.

Quality Control and Production Control

Good Manufacturing Practices (GMP) is a responsibility of:

Quality Control

FUNCTIONS OF THE _____________ IN THE GMP: To audit/to inspect periodically the procedures, equipment, and facilities employed by the various areas engaged in research, development, production, control, purchasing, distribution sale of the product.

Quality Control

FUNCTIONS OF THE _____________ IN THE GMP: To detect non compliance to CGMP and to correct them.

Manufacturing

production, preparation, propagation, compounding

Manufacturing

processing of a drug or other substance or device

Manufacturing

packaging or repackaging of such substance or device

Manufacturing

the labeling or relabeling of the commercial container of such substance or device

Manufacturing

but does not include the activities of a practitioner who has an incident to his or her administration or dispensing such substance or device in the course of his or her professional practice, prepares, compounds, packages, or labels such substance or device.

Compounding

shall be the act of combining two or more ingredients in the preparation of a prescription.

Component

any ingredient intended for use in the compounding of a drug product, including those that may not appear in such product

Pharmacist/Patient/Prescriber

Compounded drug products— Pharmacist: (1) Based on the existence of a _______/________/_________ relationship and the presentation of a valid prescription

Very Limited Quantities

Compounded drug products— Pharmacist: (2) Pharmacists may compound drugs in?

Other Persons or Commercial Entities

Compounded drug products— Pharmacist: (3) Pharmacists shall not offer compounded drug products to ________ or _______ for subsequent resale, except in the course of professional practice for a practitioner to administer to an individual patient.

Solicit Business

Compounded drug products— Pharmacist: (4) Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services; however, they shall not __________ (e.g., promote, advertise, or use salespersons) to compound specific drug products.

Manufacturing

Compounded drug products— Pharmacist: (5) The distribution of large amounts of compounded products without a prescriber/patient/pharmacist relationship is considered _____________.

Safe, Pure and Effective

MAIN OBJECTIVE OF cGMP

Safe

MAIN OBJECTIVE OF cGMP: Unable to cause damage, free danger

Pure

MAIN OBJECTIVE OF cGMP: Freedom from contamination

Effective

MAIN OBJECTIVE OF cGMP: Producing the desired effect

Quality Variation, Contamination, Mix-ups and error and Product Recalls

A. CONTAMINATION

Non- compliance to cGMP could result in the ff.:

Contamination

A. CONTAMINATION

Non- compliance to cGMP could result in the ff.: particulate, cross contamination, microbial contamination

Financial Losses

DISADVANTAGES OF PRODUCT RECALLS:

• Causes _____________.

• Bad publicity that might damage the good reputation of the company.

• Harmful publicity which can have a negative effect on sales

Bad Publicity

DISADVANTAGES OF PRODUCT RECALLS:

• Causes financial losses.

• _________ that might damage the good reputation of the company.

• Harmful publicity which can have a negative effect on sales

Negative Effect

DISADVANTAGES OF PRODUCT RECALLS:

• Causes financial losses.

• Bad publicity that might damage the good reputation of the company.

• Harmful publicity which can have a _____________ on sales

Particulate

WHAT IS THE CONTAMINATION?

SOURCES:

1. Unclean clothing

2. Clothes that shed lint and particles

3. Objects falling out of one’s pockets

4. Not following SOP’s

Particulate

WHAT IS THE CONTAMINATION?

PREVENTION:

1. Always wear clean clothing and uniform

2. Avoid wearing clothes that shed lint or particles. Wear head coverings, gloves, facial hair covering, masks, protective gear.

3. Do not use breast pocket

4. Follow SOP’s that relate to proper cleaning of equipment:

Cross Contamination

WHAT IS THE CONTAMINATION?

SOURCES:

1. Airborne particles within storage area and thru ventilation system

2. Packaging machines not cleared out prior to a new packaging run.

3. Improper dispensing of components

4. Inaccuracies and mix-ups in record-keeping.

Cross Contamination

WHAT IS THE CONTAMINATION?

PREVENTION:

1. Keep containers tightly closed and in separate

2. Follow the specific SOP’s on cleaning equipment and proper labelling and packaging procedures

3. Follow SOP’s on correct dispensing of components

4. Follow SOP’s in accurate record- keeping

Microbial

WHAT IS THE CONTAMINATION?

SOURCES:

1. People

2. SOP’s not being followed

3. Environment

Microbial

WHAT IS THE CONTAMINATION?

PREVENTION:

1. Good personal hygiene. Report all injuries and illnesses

2. Follow SOP’s on handling storage, cleaning and sterilization.

3. Monitor microbial level of environment.

Proper Education

B. PERSONNEL

THE QUALIFIED PERSONNEL SHOULD POSSESS THE FF.:

• ____________

• Proper training and experience to execute technological assignments.

Technological Assignments

B. PERSONNEL

THE QUALIFIED PERSONNEL SHOULD POSSESS THE FF.:

• Proper education

• Proper training and experience to execute?

Health Check-Ups

B. PERSONNEL

PERSONNEL HAVING DIRECT CONTACT WITH DRUGS AND COSMETICS SHOULD:

• Periodic?

• Free from contamination diseases and open lesions on the exposed surface of the body.

• Have an awareness of the importance of good personal hygiene.

• Wear clean outer garments

• Maintain a high degree of personal cleanliness

• Should conform to hygienic practices.

Contamination Diseases and Open Lesions

B. PERSONNEL

PERSONNEL HAVING DIRECT CONTACT WITH DRUGS AND COSMETICS SHOULD:

• Periodic health check-ups

• Free from _____________ and __________ on the exposed surface of the body.

• Have an awareness of the importance of good personal hygiene.

• Wear clean outer garments

• Maintain a high degree of personal cleanliness

• Should conform to hygienic practices.

Personal Hygiene

B. PERSONNEL

PERSONNEL HAVING DIRECT CONTACT WITH DRUGS AND COSMETICS SHOULD:

• Periodic health check-ups

• Free from contamination diseases and open lesions on the exposed surface of the body.

• Have an awareness of the importance of good?

• Wear clean outer garments

• Maintain a high degree of personal cleanliness

• Should conform to hygienic practices.

Outer Garments

B. PERSONNEL

PERSONNEL HAVING DIRECT CONTACT WITH DRUGS AND COSMETICS SHOULD:

• Periodic health check-ups

• Free from contamination diseases and open lesions on the exposed surface of the body.

• Have an awareness of the importance of good personal hygiene

• Wear clean?

• Maintain a high degree of personal cleanliness

• Should conform to hygienic practices.

Space

C. BUILDINGS

1. Adequate _____ for proper operation of manufacturing, processing, packaging, control and storage of products and their components

Lighting and Ventilation

C. BUILDINGS

2. Adequate _________ and _________. Facilities for adequate air-pressure, microbial/dust screening, filtering, humidity/temperature controls to minimize contamination of products.

Working Areas

C. BUILDINGS

3. Adequate locker facilities, hot and cold washing facilities (including soap, air-dryer, single-serve towels), clean toilet facilities near?

Continuous Positive Pressure

C. BUILDINGS

4. Adequate supply of potable water under ____________________, plumbing system free from defects or contamination.

Laboratory Animals

C. BUILDINGS

5. Suitable housing space for the care of all?

Sewage, Trash, and Other Refuse

C. BUILDINGS

6. Safe and sanitary disposal of _______, _________ and __________ within and from the buildings and immediate premises.

Clean and Orderly

D. EQUIPMENT

1. Maintained in a _________ and ________ manner

2. Suitable design, size, construction and location in relation to surroundings to facilitate maintenance and operation for its intended uses.

Design, Size, Construction and Location

D. EQUIPMENT

1. Maintained in a clean and orderly manner

2. Suitable _______, _______, _______ and ______ in relation to surroundings to facilitate maintenance and operation for its intended uses.

Reactive, Additive or Absorptive

D. EQUIPMENT

THE EQUIPMENT SHOULD HAVE THE FF. PROPERTIES:

• Its surface should not be ______, _____ or _______ so as to alter the properties of drug or cosmetic.

Lubricants or Colorants

D. EQUIPMENT

THE EQUIPMENT SHOULD HAVE THE FF. PROPERTIES:

• It should prevent any substance required for its operation, (such as ______ or ______) come in contact with the product.

Adjustments, Disassembly, Cleaning and Maintenance

D. EQUIPMENT

THE EQUIPMENT SHOULD HAVE THE FF. PROPERTIES:

• It should facilitate ________, _________, _______ and ________ as necessary to ensure the reliability of control procedures, uniformity of production, and exclusion of the product from contaminants from previous and current operations.

Type, Size and Accuracy

D. EQUIPMENT

THE EQUIPMENT SHOULD HAVE THE FF. PROPERTIES:

• It should be suitable ______, ______ and ______ intended for testing, measuring, mixing, weighing or other processing or storage operations.

Equipment Logbook

Entries in the ___________ should contain the ff.:

✓ Date when the equipment was used

✓ Name of the product where the equipment was used.

✓ Date when it was cleaned.

✓ Personnel responsible for cleaning it.

✓ Date when the equipment was validated.

✓ Result of validation.

Manufacture, Processing, Packaging and Holding

ADMINISTRATIVE ORDER NO. 220 s 1974 SUBJECT: CGMP IN ___________, _________, __________ AND ___________

THE SCOPE OF THIS REGULATION IS AS FOLLOWS:

• Definitions

• cGMP

• Buildings Equipment Personnel

• Components (raw materials)

• Master formula and Batch Production records

• Production and Control procedures

• Product containers Packaging and Labelling

• Laboratory controls

• Finished Goods Warehouse Distribution records

• Stability

• Complaint files

Complaint

____________ RECORDS SHOULD CONTAIN THE FF.:

• Name and address of the complainant

• Product name, strength, and control/lot number

• Nature of complaint

• Reply to the person complaining

• Results of the investigation and follow-up action that was required.

Investigation

COMPLAINT RECORDS:

If an _________ took place, the record must indicate:

a. why it was considered unnecessary

b. the name of the person responsible for that decision

Components

PRESERVATION: SAMPLES AND RECORDS

FDA recommends the ff. retention periods:

FOR _____________:

1. At least 2 years after the distribution of the last of the product incorporating the component has been completed or;

2. One year after the expiration date of thus last lot incorporating the component.

Finished Products

PRESERVATION: SAMPLES AND RECORDS

FDA recommends the ff. retention periods:

FOR ______________:

1. At least 2 years after lot distribution is completed or;

2. One year after the expiration date of the product.

Records

PRESERVATION: SAMPLES AND RECORDS

FDA recommends the ff. retention periods:

FOR ____________:

• DRUGS: At least 2 years after lot distribution is completed or; one year after the expiration date of the product

• COSMETICS: at least 3 years after the manufacture is completed.

2 Years or 1 Year

PRESERVATION: SAMPLES AND RECORDS

What is the FDA-recommended retention period for COMPONENTS

(At least ______ after distribution of the last product incorporating the component is completed, OR ______ after the expiration date of the last lot incorporating the component.)

2 Years or 1 Year

PRESERVATION: SAMPLES AND RECORDS

What is the FDA-recommended retention period for FINISHED PRODUCTS?

(At least ______ after lot distribution is completed, OR ______ after the expiration date of the product.)

2 Years or 1 Year

PRESERVATION: SAMPLES AND RECORDS

What is the FDA-recommended retention period for DRUG RECORDS?

(Same as finished products: ______ after lot distribution is completed OR ______ after the expiration date.)

3 Years

PRESERVATION: SAMPLES AND RECORDS

What is the FDA-recommended retention period for COSMETIC RECORDS?

(At least ________ after the manufacture is completed.)

Component

Administrative order no. 220 s. 1974:

“__________” (raw material) means any ingredient intended for use in the manufacturing of drugs, including those that may not appear in the finished product.

Batch

Administrative order no. 220 s. 1974:

“_____” means a specific homogenous quantity of a drug or in case of drug produced according to single manufacturing order during the same cycle of manufacture.

Lot

Administrative order no. 220 s. 1974:

“___” means a batch or any portion of batch of a drug produced by a continuous process, an amount of drug produced in a unit of time or quantity in a manner that assures its uniformity and in either case which is identified by a distinctive lot number and has uniform character and quality within specified limits.

Lot Number or Control Number

Administrative order no. 220 s. 1974:

“_________” or “________” means any distinctive combination of letters or numbers, both, by which the complete history of the manufacture, control, packaging and distribution of a batch or lot of a drug is determined.

Active Ingredient

Administrative order no. 220 s. 1974:

“___________” means any substance of a which is intended to furnish pharmacological activity or other effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man or other animals.

Inactive Ingredient

Administrative order no. 220 s. 1974:

“____________” means any substance other than “active ingredient” present in a drug.

Materials Approval Unit

Administrative order no. 220 s. 1974:

“_____________” means an organizational element having the authority and responsibility to approve or reject raw materials, in-process materials, packaging components, and final products.

Strength

Administrative order no. 220 s. 1974:

“_______” means (i) the concentration of known active drug substance in formulation (for example, w/w, w/v, or unit dose /volume basis) and/or (ii) potency, that is, the specific ability or capacity of the product as indicated by appropriate laboratory tests or by adequately controlled clinical data obtained through the administration of the product in the manner intended to effect a given result(s) expressed, for example, in terms of units by reference to a standard).

Known Active Drug Substance

Administrative order no. 220 s. 1974:

“Strength” means (i) the concentration of _______________________ in formulation (for example, w/w, w/v, or unit dose/volume basis) and/or (ii) potency, that is, the specific ability or capacity of the product as indicated by appropriate laboratory tests or by adequately controlled clinical data obtained through the administration of the product in the manner intended to effect a given result(s) expressed, for example, in terms of units by reference to a standard).

Potency

Administrative order no. 220 s. 1974:

“Strength” means (i) the concentration of known active drug substance in formulation (for example, w/w, w/v, or unit dose /volume basis) and/or (ii) ________, that is, the specific ability or capacity of the product as indicated by appropriate laboratory tests or by adequately controlled clinical data obtained through the administration of the product in the manner intended to effect a given result(s) expressed, for example, in terms of units by reference to a standard).