Manuf Internship Exit Report

Manufacturing Internship at Lloyd Laboratories, Inc.

Gilberto DianoVincent Rebultan

Kristina Gayle RodriguezJune 18, 2011

Company ProfileVision-Mission and Core Values

COM

PAN

Y PR

OFI

LE• Founded in Marikina in 1989• Corporate turnover of $10,000,000• Manufacturing facilities in Bulacan and Quezon

City in the Philippines and in India (Lloyd Laboratories, Private Limited)

• Major player in the pharmaceutical industry in the Philippines and in India

VISI

ON

• To support our marketing partners with the latest innovations in Pharmaceutical technology

• To become a global leader as a manufacturer of health care products by providing solutions and alternatives,

• To uplift the health and well-being of people.

MIS

SIO

N• To utilize the latest technology and provide

significant added value to our partner• To build a diverse, productive and challenging

workplace• To achieve market leadership in all segments of

our product line

CORE

VAL

UES

• We live, breath and exist in pursuit of products and services aimed at improving life.

• We exemplify honesty and integrity in all our actions.

• We are committed in taking care of our people and in giving them the opportunity to grow, to develop and to continuously exceed themselves.

• We accept and take on our social responsibility to the community we belong to.

• We believe in the higher purpose of things, to the greater responsibility of our existence and to the real reason for our being.

Quality Policy and ISO CertificationProducts and Services

QU

ALIT

Y PO

LICY

Strict adherence to USFDA, WHO, ISO and other statutory cGMP guidelines such as :• TGA-Australia (Therapeutics Goods

Administration)• UK-MHRA (United Kingdom Medicines &

Healthcare Products Regulatory Agencies)• MCC-South Africa (Medicines Control Council)• ANVISA-Brazil (National Health Surveillance

Agency)• INVIMA-Colombia (National Institute for the

Supervision of Foods and Medications)

QU

ALIT

Y PO

LICY

• Providing quality products and services that meet National and International Standards

• Routine training, effective communication and team building

• Continual upgrading of technical and quality systems

ISO Certification 9001:2000December 17, 1998The ISO 9001:2000 standard provides a

tried and tested framework for taking a systematic approach to managing the organization’s processes so that they consistently turn out product that satisfies customers’ expectationsIS

O C

ERTI

FICA

TIO

N

Toll ManufacturerPharmaceutical

Anti-infectives (e.g. Co-Amoxiclav, Anti-TB drugs), Analgesic, Anti-HPN, Antacid, Antidiabetic

CosmeticsPerfumes (e.g. Tupperware®, ), Detergent Powder, Lubricant (Bliss®), Facial cream (Placenta®)

HerbalTablets, capsules, Tea (e.g. Liveraide®, Taheebo®, Jimms® )PR

OD

UCT

S &

SER

VICE

S

Contract PackagingSecondary/Re-packaging of drugs manufactured by other companies and imported from other countries • Silver Sulfadiazine (Flammazine) Solvay

Pharma • Glucophage XR (Metformin) Merck

PRO

DU

CTS

& S

ERVI

CES

Organizational StructurePlant Layout and FacilitiesEquipment

PresidentVice PresidentChairmanPlant ManagerAVP

Manuf I, Manuf IICosmeticsQAQCMaterials ManagementO

RGAN

IZAT

ION

AL S

TRU

CTU

RE

ORGANIZATIONAL STRUCTURE

ORGANIZATIONAL STRUCTURE

PLANT LAYOUT

Penicillin

Cefalexin

Warehouse 1

(1) Dispensing(2) QA

Cool Room

(1) Solids(2) Liquids & QC(3) Cosmetics

Warehouse (CSI)

Warehouse 2

Gym

(1) Canteen(2) Offices

GR2 Clinic & Offices GR1

GH

Cold Storage A4 Blister Making

FACI

LITI

ESManufacturing ICompounding and packaging area for non-penicillin pharmaceutical products

SolidsUncoated & coated tablets, capsules, pellets

LiquidsSyrups, solutions, suspensions

Class 100,000 Area

FACI

LITI

ESManufacturing IICompounding and packaging area for penicillins & cephalosphorins

SolidsUncoated & coated tablets, capsules, pellets

LiquidsSyrups, solutions, suspensions

Class 100,000 Area

FACI

LITI

ESCosmetics Specialist, Inc. Production and packaging of cosmetics & household products

FACI

LITI

ESMaterials ManagementWarehouse; Storage for raw materials, bulk products, packaging materials and finished goods

Dispensing SectionBatching of raw materials for productionClass 1000

Quality Assurance OfficeSampling of raw materialsInspection of BP, PM & FG

FACI

LITI

ESQuality ControlAnalysis of raw materials, bulk products and finished goods (both pharma and cosmetic products)

EQU

IPM

ENT

Production

Fluid Bed DryerGels Cream MixerMixing Tanks*Labeling MachineCartoning MachineInkjet PrinterBlistering MachineStrip Packing MachineVolumetric Filling MachineRibbon MixerSachet Filling

EQU

IPM

ENT

Quality Control/Quality AssuranceDigital Caliper and Stokes-Monsato Hardness TesterAtomic Absorption SpectrophotometerFourier Transform Infrared & Near Infrared*Karl Fischer Titration ApparatusGas-Liquid ChromatographyMoisture DeterminationHPLCpH MeterDissolution ApparatusDisintegration ApparatusUV SpectrophotometerPolarimeterAutomated Micrometer

Knowledge and Skills AcquiredInsights

• Inquisitiveness• Increased sociability• Independence• Respect for and camaraderie with all,

regardless of position• Solidarity• Flexibility and hand dexterity• Cost-consciousness and speed

KNO

WLE

DG

E &

SKI

LLS

ACQ

UIR

ED

• Fortunate to be given the chance to evaluate the various departments – Opportunity to voice out concerns directly to supervisors in exit report

• The value of work – Learned about the hardships of Lloyd employeesIN

SIG

HTS

Problems Encountered(Aside from the fact that there were so many pretty

female interns and there’s only one Bert)

These are excerpts from our Exit Report on the cGMP Evaluation of the Various Departments of Lloyd.

Personnel

Professionalism, particularly with regards to the mode of interpersonal communication, must be observed at all times.

Inconsistent use of hard hats and safety shoes (Warehouse)

Some personnel are not properly clad with required lab attire and safety equipment (e.g. gloves). (Solids)

Premises

Bench in the gowning room is not utilized

properly Inadequate space in Liquids Department

specifically in Cartoning Line 1 Some employees are not properly clad with

their required laboratory gown especially in the compounding area. (Pen)

Inadequacy of working space hindering orderly and logical placement of equipment and materials to suit the operation and efficient flow of work. (Pen)

Premises

Materials are not properly stored in

orderly manner due primarily to inadequate space. They are stored off the floor and not sufficiently spaced. (Warehouse)

Materials are not stored under suitable environmental conditions.

There is insufficient ventilation and conditions are not monitored. (Cosmetics)

Inadequate practice of hand washing before and after entering the area and absence of (visual) reminders regarding this practice

Incomplete protective clothing (e.g. gloves for personnel involving in strip packaging and face masks for the stripping operator).

Smoking, drinking, keeping food, and use of perfume

Sanitation and Hygiene

The manual transfer of bulk material from its container to the machine is performed without gloves (CSI)

Unassigned operator that manipulate the machine with dirty hands (CSI)

Sanitation and Hygiene

Work Process

Lack of conscientiousness towards the work

process Operating with an open wound Dirty packaging materials returned at the assembly

line without decontaminating measures (e.g. measuring cup)

Rough handling of packaging materials (e.g. amber bottles)

Infrequent use of washing bottle when titrating (QC)

Illogical procedure in performing dissolution & UV spec testing (QC)

Malfunctioning of sealing machine was not addressed immediately resulting in incomplete or burned seals. (Pen)

Usage of plastic measuring apparatus (QC)

Some machines are rusty Filling machine frequently

malfunctions, causing several delays in production in a single run

Equipment

Recommendation

To allot less time in packaging and more time in Quality Control and to explore

other departments (e.g. PPIC, Arts/Documentation)

END